Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Posts Tagged ‘Prostate cancer screening’

In Search of Clarity on Prostate Cancer Screening, Post-Surgical Followup, and Prediction of Long Term Remission

Posted in Biomarkers & Medical Diagnostics, CANCER BIOLOGY & Innovations in Cancer Therapy, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Industry Competitive Intelligence, tagged Cancer - General, Conditions and Diseases, evidence based medicine, Prostate cancer, Prostate cancer screening, Prostate-specific antigen, PSA on May 23, 2013| 1 Comment »

In Search of Clarity on Prostate Cancer Screening, Post-Surgical Followup, and Prediction of Long Term Remission

Larry H. Bernstein, MD, FCAP, Author and Curator
Dror Nir, PhD, Curator
Aviva Lec-Ari, PhD, RN, Curator

• 

There have been two important articles in the last several days giving perspectives on the current and evolving status of current and evolving diagnosis of prostate cancer (PCA) by experts Dror Nir, PhD and Aviva Lev-Ari, PhD, RN, Editor-in-Chief, http://Pharmaceuticalintelligence.com

The first article reviews the recent published update on PCA screening and diagnosis, as determined by review of the literature by an Expert Panel, in order to determine what is the current validated Evidence-Based Medicine Practice Guideline for American Urological Surgeons.

The method of review is rigorously laid out and follows the accepted standard for publication.  The emphasis in the study lies in the reliance on prostate specific abtigen (PSA), which has undergone an evolutioary improvement sine 1999, although substantiation of a benefit could not be trusted until almost a decade later.   The problem the is notable is the absence of discussion of improvements in cancer imaging that has also evolved in that time period, and continues to evolve with molecular probes.

Early Detection of Prostate Cancer: American Urological Association (AUA) Guideline

Author-Writer: Dror Nir, PhD

http://pharmaceuticalintelligence.com/2013/05/21/early-detection-of-prostate-cancer-aua-guideline/

When reviewing the DETECTION OF PROSTATE CANCER section on the AUA website , The first thing that catches one’s attention is the image below; clearly showing two “guys” exploring with interest what could be a CT or MRI image….

But, if you bother to read the review underneath this image regarding EARLY DETECTION OF PROSTATE CANCER: AUA GUIDELINE produced by an independent group that was commissioned by the AUA to conduct a systematic review and meta-analysis of the published literature on prostate cancer detection and screening; Panel Members: H. Ballentine Carter, Peter C. Albertsen, Michael J. Barry, Ruth Etzioni, Stephen J. Freedland, Kirsten Lynn Greene, Lars Holmberg, Philip Kantoff, Badrinath R. Konety, Mohammad Hassan Murad, David F. Penson and Anthony L. Zietman – You are bound to be left with a strong feeling that something is wrong!

“The AUA commissioned an independent group to conduct a systematic review and meta-analysis of the published literature on prostate cancer detection and screening. The protocol of the systematic review was developed a priori by the expert panel. The search strategy was developed and executed by reference librarians and methodologists and spanned across multiple databases including Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials and Scopus. Controlled vocabulary supplemented with keywords was used to search for the relevant concepts of prostate cancer, screening and detection. The search focused on DRE, serum biomarkers (PSA, PSA Isoforms, PSA kinetics, free PSA, complexed PSA, proPSA, prostate health index, PSA velocity, PSA doubling time), urine biomarkers (PCA3, TMPRSS2:ERG fusion), imaging (TRUS, MRI, MRS, MR-TRUS fusion), genetics (SNPs), shared-decision making and prostate biopsy. The expert panel manually identified additional references that met the same search criteria”

While reading through the document, I was looking for the findings related to the roll of imaging in prostate cancer screening; see highlighted above. The only thing I found: “With the exception of prostate-specific antigen (PSA)-based prostate cancer screening, there was minimal evidence to assess the outcomes of interest for other tests.”

This must mean that: Notwithstanding hundreds of men-years and tens of millions of dollars which were invested in studies aiming to assess the contribution of imaging to prostate cancer management, no convincing evidence to include imaging in the screening progress was found by a group of top-experts in a thorough and rigorously managed literature survey! And it actually  lead the AUA to declare that “Nothing new in the last 20 years”…..

My interpretation of this: It says-it-all on the quality of the clinical studies that were conducted during these years, aiming to develop an improved prostate cancer workflow based on imaging. I hope that whoever reads this post will agree that this is a point worth considering!

For those who do not want to bother reading the whole AUA guidelines document here is a peer reviewed summary:

“Early Detection of Prostate Cancer: AUA Guideline; Carter HB, Albertsen PC, Barry MJ, Etzioni R, Freedland SJ, Greene KL, Holmberg L, Kantoff P, Konety BR, Murad MH, Penson DF, Zietman AL; Journal of Urology (May 2013)”

It says:

“A systematic review was conducted and summarized evidence derived from over 300 studies that addressed the predefined outcomes of interest (prostate cancer incidence/mortality, quality of life, diagnostic accuracy and harms of testing). In addition to the quality of evidence, the panel considered values and preferences expressed in a clinical setting (patient-physician dyad) rather than having a public health perspective. Guideline statements were organized by age group in years (age<40; 40 to 54; 55 to 69; ≥70).

RESULTS: With the exception of prostate-specific antigen (PSA)-based prostate cancer screening, there was minimal evidence to assess the outcomes of interest for other tests. The quality of evidence for the benefits of screening was moderate, and evidence for harm was high for men age 55 to 69 years. For men outside this age range, evidence was lacking for benefit, but the harms of screening, including over diagnosis and over treatment, remained. Modeled data suggested that a screening interval of two years or more may be preferred to reduce the harms of screening.

Prostate Cancer Molecular Diagnostic Market – the Players are: SRI Int’l, Genomic Health w/Cleveland Clinic, Myriad Genetics w/UCSF, GenomeDx and BioTheranostics

Curator: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/05/21/prostate-cancer-molecular-diagnostic-market-the-players-are-sri-intl-genomic-health-wcleveland-clinic-myriad-genetics-wucsf-genomedx-and-biotheranostics/

On February 6, 2013 we reported that DR. MARK RUBIN, LEADING PROSTATE CANCER AND GENOMICS EXPERT, TO LEAD CUTTING-EDGE CENTER FOR TARGETED, INDIVIDUALIZED PATIENT CARE BASED ON EACH PATIENT’S GENETICS

Genomically Guided Treatment after CLIA Approval: to be offered by Weill Cornell Precision Medicine Institute

On May 16, 2013 we reported a major breakthrough in the Prostate Cancer Screening

A Blood Test to Identify Aggressive Prostate Cancer: a Discovery @ SRI International, Menlo Park, CA

After nearly a decade, my collaborators and I have found the first marker that specifically identifies the approximately six to eight percent of prostate cancers that are considered “aggressive,” meaning they will migrate to other parts of the body, at which point they are very difficult to treat. Although we have confirmed this marker, there is much to be done before a clinical application can be developed.

http://pharmaceuticalintelligence.com/2013/05/16/a-blood-test-to-identify-aggressive-prostate-cancer-a-discovery-sri-international-menlo-park-ca/

Prostate Cancer MDx Competition Heating Up; New Data from Genomic Health, Myriad

May 15, 2013  By Turna Ray

Life sciences companies are gearing up for battle to capture the profitable prostate cancer molecular diagnostic market.

Genomic Health and Myriad Genetics both made presentations to the investment community last week about their genomic tests that gauge a man’s risk of prostate cancer aggressiveness. As part of its annual investor day, Myriad discussed new data on its Prolaris test, which analyzes the expression level of 46 cell cycle progression genes and stratifies men’s risk of biochemical recurrence of prostate cancer. If the test reports low gene expression, then the patient is at low risk of disease progression, while high gene expression is associated with disease progression.

Meanwhile, around the same time last week, Genomic Health launched its Oncotype DX prostate cancer test and presented data from the first validation study involving the diagnostic. The Oncotype DX prostate cancer test analyzes the expression of 17 genes within four biological pathways to gauge prostate cancer aggressiveness. The test reports a genomic prostate score from 0 to 100; the lower the score the more certain a patient can be that they can avoid treatment and continue with active surveillance. Prostate cancer patients who are deemed to be at very low risk, low risk, or intermediate risk of progressing are eligible to be tested with the Oncotype Dx test. If, based on standard clinical measures, a person’s prostate cancer is considered high risk, then he is not a candidate for Genomic Health’s test.

These molecular tests are entering the market at a time when currently available tools aren’t specific enough to distinguish between men who have an aggressive form of prostate cancer and therefore, need invasive treatments, and those that are low risk and can do well with active surveillance. According to an NIH estimate, in 2010, the annual medical costs associated with prostate cancer in the US were $12 billion.

It is estimated that each year 23 million men undergo testing for prostate specific antigen, a protein produced by the prostate gland that increases when a man has prostate cancer. Additionally, one million men get a prostate biopsy annually, while 240,000 men end up with a diagnosis for prostate cancer, and around 30,000 die from the disease. Although most of the men diagnosed with prostate cancer end up receiving surgery or radiation treatment, as many as half of these men will probably not progress, and their disease isn’t life threatening.

While PSA testing has been shown to reduce prostate cancer deaths, a man’s PSA level may be increased for reasons other than cancer. As such, broadly screening men for PSA has been controversial in the healthcare community since the test isn’t specific enough to gauge which men are at low risk of developing aggressive prostate cancer and can forgo unnecessary treatments that can have significant side effects.

Both Myriad and Genomic Health are hoping their tests will further refine prostate cancer diagnosis and help doctors gain more confidence in determining which of their patients have aggressive disease and which are at low risk.

Myriad’s advantage

In this highly competitive space, Myriad has the first mover advantage, having launched Prolaris three years ago. The company has published four studies involving the test and conducted a number of trials analyzing around 3,000 patient samples.

Researchers from UCSF and Myriad recently published the fourth validation study in the Journal of Clinical Oncology, which analyzed samples from 400 men who had undergone a radical prostatectomy. In the published study, researchers reported that 100 percent of the men whom Prolaris deemed to be at “low risk” of progression did not experience a recurrence within the five years the study was ongoing. Meanwhile, 50 percent of those the test deemed to be a “high risk” did experience recurrence during that time (PGx Reporter 3/6/2013).

New competition

Like Myriad’s BRACAnalysis test, which comprises more than 80 percent of its product revenues, Genomic Health’s Oncotype DX breast cancer recurrence tests is bringing in the majority of its product revenues. However, the company believes that its newly launched Oncotype DX prostate cancer test stands to be its largest market opportunity to date.

Last week, researchers from University of California, San Francisco, presented data from the first validation study involving the Oncotype DX prostate cancer test. The study involved nearly 400 prostate cancer patients considered low or intermediate risk by standard methods such as Gleason score and showed that when the Oncotype DX score was used in conjunction with other measures, investigators identified more patients as having very low risk disease who were appropriate for active surveillance than when they diagnosed patients without the test score.

More than one third of patients classified as low risk by standard measures in the study were deemed to be “very low risk” by Oncotype DX and therefore could choose active surveillance. Meanwhile, 10 percent of patients in the study were found by clinical measures to be at very low risk or low risk, but the Oncotype DX test deemed them as having aggressive disease that needed treatment.

Matthew Cooperberg of UCSF, who presented data from this validation study at the American Urological Association’s annual meeting last week, highlighted this feature of the Oncotype DX prostate cancer test to investors during a conference call last week. He noted that the test not only gauges which low-risk patients can confidently remain with active surveillance, but it also finds those patients who didn’t receive an accurate risk assessment based on standard clinical measures. “It’s also equally important that we identify the man who frankly should not be on active surveillance, because they’re out there,” he said.

Genomic Health has aligned its test with guidelines from the National Comprehensive Cancer Network, which has expressed concern about over-diagnosis and over-treatment in prostate cancer patients. In 2010, NCCN guidelines established a new “very low risk” category for men with clinically insignificant prostate cancer and recommended that men who fall into this category and have a life expectancy of more than 20 years should only be followed with active surveillance. In 2011, NCCN made the active surveillance criteria more stringent for men in the “very low risk” category.

In order to develop the prostate cancer test, Genomic Health collaborated with the Cleveland Clinic on six feasibility studies and selected the gene expression panel after analyzing 700 genes on tissue samples from 700 patients. The commercial test analyzes the expression of 17 genes across four biological

I am quite surprised that nothing is said about the current status of  PSA for Pca, which is far advanced today, and it also needs attention.  We are in the old SUFI tale about the blind men who grasped the trunk, or the tail, etc., and called it the elephant.

Robustness of ProsVue™ linear slope for prognostic identification of patients at reduced risk for prostate cancer recurrence: Simulation studies on effects of analytical imprecision and sampling time variation

Mark J. Sarno, Charles S. Davis

Clinical Biochemistry  Nov 2012;  45 (16–17): 1479-1484

 

Highlights

► We simulate effects of analytical and sampling time variation on ProsVue slope.

 ► Classification switching is minimal in both stable disease and recurrence.

 ► We provide a framework for assessment of assays using rate of change principles

Objective

The ProsVue assay measures serum total prostate-specific antigen (PSA) over three time points post-radical prostatectomy and calculates rate of change expressed as linear slope. Slopes ≤ 2.0 pg/ml/month are associated with reduced risk for prostate cancer recurrence. However, an indicator based on measurement at multiple time points, calculation of slope, and relation of slope to a binary cutoff may be subject to effects of analytical imprecision and sampling time variation. We performed simulation studies to determine the presence and magnitude of such effects.

Design and methods

Using data from a two-site precision study and a multicenter clinical trial of 304 men, we performed simulation studies to assess whether analytical imprecision and sampling time variation can drive misclassifications or classification switching of patients with stable disease or recurrence.

Results

Analytical imprecision related to expected PSA values in a stable disease population results in ≤ 1.2% misclassifications. For populations with recurrent disease, an analysis taking into account correlation between sampling time points demonstrates that classification switching across the 2.0 pg/ml/month cutoff occurs at a rate ≤ 11%. In the narrow region of overlap between populations, classification switching maximizes at 12.3%. Lastly, sampling time variation across a wide range of scenarios results in 99.7% retention of proper classification for stable disease patients with linear slopes up to the 75th percentile of the distribution.

Conclusions

These results demonstrate the robustness of the ProsVue assay and the linear slope indicator. Further, these simulation studies provide a potential framework for evaluation of future assays that rely on the rate of change principle.

 

As the reviewer of this paper for Clinical Biochemistry, I have never encountered such a beautiful and rigorous evaluation that is described in the outline below:

 

Article Outline

1. Introduction

2. Materials and Methods

2.1. Source data

2.2. Simulation 1 – Effects of analytical imprecision in patients with stable disease

2.3. Simulations 2 and 3 – Effects of analytical imprecision in patients with PCa recurrence

2.4. Simulations 4 and 5 – Simulations in highest tertile of stable disease slopes and lowest tertile of recurrent slopes

2.5. Simulation 6 – Effects of sampling time variation

2.6. Software

3. Results

3.1. Source data for simulations

3.2. Simulation 1 – Effects of analytical imprecision in patients with stable disease

3.3. Simulations 2 and 3 – Effects of analytical imprecision in patients with PCa recurrence

3.4. Simulations 4 and 5 — Simulations in highest tertile of stable disease slopes and lowest tertile of recurrent slopes

3.5. Simulation 6 – Effects of sampling time variation

4. Discussion

5. Conclusions

References

 

This article is followed by another in the Urology journal.

NADiA ProsVue prostate-specific antigen slope is an independent prognostic marker for identifying men at reduced risk of clinical recurrence of prostate cancer after radical prostatectomy.

 

Moul JW, Lilja H, Semmes OJ, Lance RS, Vessella RL, Fleisher M, Mazzola C, Sarno MJ, Stevens B, Klem RE, McDermed JE, Triebell MT, Adams TH.

Division of Urologic Surgery and Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina 27710, USA. judd.moul@duke.edu

Urology. 2012 Dec;80(6):1319-25. http://dx.doi.org/10.1016/j.urology.2012.06.080. Epub 2012 Oct 26.

OBJECTIVE:

To validate the hypothesis that men displaying serum prostate-specific antigen (PSA) slopes ≤ 2.0 pg/mL/mo after prostatectomy, measured using a new immuno-polymerase chain reaction diagnostic test (NADiA ProsVue), have a reduced risk of clinical recurrence as determined by positive biopsy, imaging findings, or death from prostate cancer.

MATERIALS AND METHODS:

From 4 clinical sites, we selected a cohort of 304 men who had been followed up for 17.6 years after prostatectomy for clinical recurrence. We assessed the prognostic value of a PSA slope cutpoint of 2.0 pg/mL/mo against established risk factors to identify men at low risk of clinical recurrence using uni- and multivariate Cox proportional hazards regression and Kaplan-Meier analyses.

RESULTS:

The univariate hazard ratio of a PSA slope >2.0 pg/mL/mo was 18.3 (95% confidence interval 10.6-31.8) compared with a slope ≤ 2.0 pg/mL/mo (P <.0001). The median disease-free survival interval was 4.8 years vs >10 years in the 2 groups (P <.0001). The multivariate hazard ratio for PSA slope with the covariates of preprostatectomy PSA, pathologic stage, and Gleason score was 9.8 (95% confidence interval 5.4-17.8), an 89.8% risk reduction for men with PSA slopes ≤ 2.0 pg/mL/mo (P <.0001). The Gleason score (<7 vs ≥ 7) was the only other significant predictor (hazard ratio 5.4, 95% confidence interval 2.1-13.8, P = .0004).

CONCLUSION:

Clinical recurrence after radical prostatectomy is difficult to predict using established risk factors. We have demonstrated that a NADiA ProsVue PSA slope of ≤ 2.0 pg/mL/mo after prostatectomy is prognostic for a reduced risk of prostate cancer recurrence and adds predictive power to the established risk factors.

Urology. 2012 Dec;80(6):1325-6; author reply 1326-7. http://dx.doi.org/10.1016/j.urology.2012.06.081. Epub 2012 Oct 26.      Collins S.

Editorial comment.

NADiA ProsVue prostate-specific antigen slope is an independent prognostic marker for identifying men at reduced risk of clinical recurrence of prostate cancer after radical prostatectomy. [Urology. 2012]

 

Why NADiA ProsVue?      IRIS INTERNATIONAL

http://www.irispermed.com/patients/why-nadia-prosvue

Some patients who had surgery to remove the prostate may be at higher risk for recurrence. Determining the risk of recurrence is critical for these patients and their physicians in order to make the most informed decision possible about future medical management.

Physicians use post-surgical risk assessment to review a variety of parameters to help determine if the patient might develop recurrent disease.  Risk factors may include:

• The size and proximity of the tumor at the time of surgery (whether it has grown through the prostate walls):

Through imaging tests, physicians can determine how far cancerous tissue may have spread, with indicators such as

• extracapsular extensions (ECE, beyond the prostatic capsule) and
• seminal vesicle invasion (SVI, presence in the walls of the vesicles surrounding the prostate).
• The presence of cancer cells at the edge of the removed tumor (known as positive margins) or in the lymph nodes outside the prostate.
• A high preoperative PSA level (> 20 ng/mL).
• The tumor’s Gleason Score (if it is at least 8 or higher).

However, current risk assessment relies on subjective and imprecise information. This uncertainty can have a dramatic impact on a patient’s personal experience after prostatectomy.

The newly available NADiA ProsVue test may help provide a more clear and accurate prediction of a patient’s true risk for clinical recurrence.
The NADiA ProsVue test measures

• the rate of change of PSA at extremely low levels over time, which can help quickly and accurately identify patients
• who are at reduced risk for clinical recurrence.

In conjunction with other information, NADiA ProsVue may allow some men to avoid unnecessary treatments and anxiety after prostatectomy.

NADiA ProsVue is an in-vitro diagnostic assay for determining

• rate of change of serum total prostate specific antigen (tPSA) over a period of time (slope, pg/mL per month).

The NADiA ProsVue assay is performed for patients having less than 0.1 ng/mL serum tPSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy.

What is NADiA?

NADiA stands for Nucleic Acid Detection immunoassay.  Immuno-PCR, first described by Sano and Cantor in 1992 involves combining protein antigen detection by immunoassay with the detection sensitivity and precision of real-time polymerase chain reaction (qPCR).  This amplified DNA-immunoassay approach is similar to that of an enzyme immunoassay, involving antibody binding reactions and intermediate washing steps.  The enzyme label is replaced by a strand of DNA and detected by exponential amplification using qPCR.

http://www.irispermed.com/images/pictures/thumbnails/thumb_NADiA_Technology1.jpg

 

NADiA employs a soluble (reporter) monoclonal antibody (MAb) labeled with an assay-specific double-stranded DNA sequence.

• The presence of this DNA label does not interfere with MAb binding, nor
• does the MAb interfere with DNA label amplification and detection.
• The second (capturing) MAb specific for another site on the target protein (antigen)
  is coated onto paramagnetic microparticles.

The reporter MAb-DNA conjugate is reacted with sample in a microtiter plate format to form a first immune complex with the target antigen. The immune complex is then captured onto paramagnetic particles coated with the second capture MAb, forming an insoluble sandwich immune complex. The microparticles are washed by several cycles of magnetic capture and re-suspension to remove excess reporter MAb-DNA conjugate.
The specifically bound DNA label is then detected by subjecting

• suspended particles to qPCR conditions and monitoring the generations of amplicon in real time.

What are possible clinical applications?

Proteins play a crucial role in all biological functions. Identifying and measuring the quantity of specific proteins is fundamental to understanding the cause and evolution of many human disease processes.
There are hundreds of thousands of proteins in the human body, but the vast majority are present at extremely low concentrations. For example, only ten (10) proteins make up 90% of the mass of plasma proteins found in human serum. Twelve (12) proteins make up another 9% of the mass. The remaining proteins comprise the final 1%. Advancing medicine through the study of proteins (known as proteomics) requires powerful and sensitive tools.
http://www.irispermed.com/images/pictures/Protein_Slide_2.png

NADiA combines the specificity of an immunoassay with the detection sensitivity of qPCR and can assist efforts to provide clinical insight into many human diseases.  Any disease process involving proteins below the detection limits of today’s enzyme immunoassays (EIA) is a potential target for NADiA.

NADiA ProsVue is the first of a line of assays designed to advance human healthcare in the areas of oncology and infectious disease.

http://www.irispermed.com/images/pictures/Major_Plasma_Proteins.jpg

 

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY

A. 510(k) Number:

k101185

B. Purpose for Submission:

New device

C. Measurand:

Total Prostate specific antigen (tPSA)

D. Type of Test:

Quantitative, Immuno-PCR (Polymerase Chain Reaction)

E. Applicant:

Iris Molecular Diagnostics

F. Proprietary and Established Names:

NADiA® ProsVue™

 

 Intended Use:

NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month). The NADiA® ProsVue™ assay is performed for patients having less than 0.1 ng/mL serum total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. ProsVue™ slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy.

The NADiA® ProsVue™ assay is not intended for the diagnosis or for the monitoring of prostate cancer.

 †”Recurrence” is defined as clinical recurrence, not biochemical recurrence, and was documented by positive imaging, positive biopsy, or death due to prostate cancer.

U.S. FDA approves NADiA ProsVue prognostic test for prostate cancer

Posted on September 23, 2011 by Sitemaster

According to a media release issued

Moul et al. have now conducted a retrospective, multi-center clinical trial to further evaluate the potential prognostic value of ProsVue slope at a decision threshold of 2 pg/ml/month. (One nanogram or 1 ng = 1,000 picograms or 1,000 pg.)

The retrospective analysis was based on data from 392 prostate cancer patients who had been given radical prostatectomies between November 1991 and August 2001. To be eligible for this study, all of the following data had to be available from individual patients:

1. A first post-surgical PSA level of <100 pg/ml (i.e., <  0.1 ng/ml)
2. Full pathologic and radiographic data
3. Three frozen serum samples drawn between 6 weeks and 19.4 months post-surgery.
4. Patients were not eligible if they had received adjuvant radiotherapy and/or hormone therapy after surgery and prior to completion of the three post-surgical blood draws.

The results of this retrospective study showed that:

1. The average (median) PSA levels of the 392 patients was 6.3 ng/ml (range, 0 to 60.6 ng/ml)
2. The average (median) post-surgical Gleason score was 7.0 (range, 4 to 10).

73 patients had received neoadjuvant hormone therapy prior to their surgery.

The pathologic stages of the patients were

pT0-2, n = 228

pT3, n = 147

pT4, n = 17

116 patients had positive margins and 8 had positive lymph nodes.

The three post-surgical PSA values were based on serum drawn

• after median times of 4.9, 8.6, and 12.8 months and showed median values of 10.7, 23.0 and 50.7 pg/ml, respectively.

The sensitivity, specificity, PPV and NPV for a 2 pg/mL/month ProsVue slope were 75.0, 96.6, 81.4, and 95.2, respectively.

• At a median follow-up of 10.5 years, 14 patients had died of prostate cancer and 40 had died overall.

The authors conclude the the ProsVue test “provides information previously unknown” in patients in the first year post-surgery, and that a ProsVue slope of  ≤ 2 pg/mL/month in that first year is highly associated with a lack of evidence of progression in long-term follow-up.

In theory, the ProsVue test may have some clinical value in the identification of patients who do not need long-term oncologic follow-up and in predicting the need for adjuvant radiation therapy. However, additional prospective studies will be necessary before this can be confirmed, and the practical clinical value of such a test would depend on whether it is significantly more accurate that data currently available from ultrasensitive PSA testing.

Additional information is available in a media release from the developer of the ProsVue test (IRIS International). According to that media release, the developer has submitted data to the FDA requesting approval to market this test.

The centers involved in this study included Duke University, Memorial Sloan-Kettering Cancer Center, Eastern Virginia Medical Center, and the University of Washington — all of which are highly reputable institutions.

NADiA ProsVue results are calculated as the linear slope of three NADiA ProsVue total PSA test results obtained on three serum samples collected between six weeks and 20 months post-radical prostatectomy.

http://www.irispermed.com/images/pictures/NADiA_ProsVue_Timeline.jpg

 

by IRIS International, the U.S. Food & Drug Administration (FDA) has approved the company’s NADiA® ProsVue™ test as a prognostic marker that can “aid in identifying” men at reduced risk for recurrence of prostate cancer in the first 8 years after a prostatectomy

 

NADiA ProsVue: A prognostic test for identifying men at a reduced risk for prostate cancer recurrence following radical prostatectomy

J. Moul2, R. Lance1, J. Alter3, M. Sarno3, J. McDermed3
1 Eastern Virginia Medical School, Norfolk, USA
2 Duke Prostate Center, Durham, USA
3 Iris Molecular Diagnostics, Carlsbad, USA

Introduction: Clinical recurrence after radical prostatectomy (RP) is difficult to predict since established factors do not reliably stratify risk. We validated a pre-specified hypothesis that a post-RP NADiA® PSA slope cutpoint of ≤2.0 pg/mL/month (mo) identifies men at reduced risk of clinical recurrence as determined by positive biopsy, imaging or prostate cancer death. This study aimed to compare the prognostic strength of the ProsVue slope cutpoint vs. surgical margin status to identify men at very low risk of post-RP clinical recurrence.
Methods: From a cohort of 304 men, surgical margin data was available for 234 men. PSA was measured with a Nucleic Acid Detection Immunoassay (NADiA®) having a limit of quantification of 0.00065 ng (0.65 pg) per mL. Least-squares linear PSA slope (ProsVue™) was calculated using 3 serum samples drawn 1.5-20 mo post-RP. Recurrence risk using a 2.0 pg/mL/mo ProsVue cutpoint and surgical margin status were compared by two survival methods, univariate Cox proportional hazards regression analysis (table) and Kaplan-Meier plots (figure).
Results: ProsVue slope ≤2.0 pg/mL/mo was significantly associated with a reduced risk of clinical recurrence by univariate Cox analysis (HR 18.3, 95% CI, 10.6–31.8, P < 0.0001). A negative surgical margin was less significantly associated with a reduced risk of recurrence (HR 3.3, 95% CI 2.0–5.4). Median time to recurrence for men with ProsVue slope ≤2.0 pg/mL/mo and those with negative margins exceeded 17.6 years (yrs). However, median time to recurrence in men with ProsVue slope >2.0 pg/mL/mo was shorter compared to those with positive margins.

NADiA ProsVue Prostate-specific Antigen Slope Is an Independent Prognostic Marker for Identifying Men at Reduced Risk of Clinical Recurrence of Prostate Cancer After Radical Prostatectomy

Judd W. Moul, Hans Lilja, O. John Semmes, Raymond S. Lance, Robert L. Vessella, Martin Fleisher, Clarisse Mazzola, Mark J. Sarno, Barbara Stevens, Robert E. Klem, Jonathan E. McDermed, Melissa T. Triebell, Thomas H. Adams
Urology Dec 2012; 80(6): 1319-1327,

Objective
To validate the hypothesis that men displaying serum prostate-specific antigen (PSA) slopes ≤2.0 pg/mL/mo after prostatectomy, measured using a new immuno-polymerase chain reaction diagnostic test (NADiA ProsVue), have a reduced risk of clinical recurrence as determined by positive biopsy, imaging findings, or death from prostate cancer.
Materials and Methods
From 4 clinical sites, we selected a cohort of 304 men who had been followed up for 17.6 years after prostatectomy for clinical recurrence. We assessed the prognostic value of a PSA slope cutpoint of 2.0 pg/mL/mo against established risk factors to identify men at low risk of clinical recurrence using uni- and multivariate Cox proportional hazards regression and Kaplan-Meier analyses.
Results
The univariate hazard ratio of a PSA slope >2.0 pg/mL/mo was 18.3 (95% confidence interval 10.6-31.8) compared with a slope ≤2.0 pg/mL/mo (P <.0001). The median disease-free survival interval was 4.8 years vs >10 years in the 2 groups (P <.0001). The multivariate hazard ratio for PSA slope with the covariates of preprostatectomy PSA, pathologic stage, and Gleason score was 9.8 (95% confidence interval 5.4-17.8), an 89.8% risk reduction for men with PSA slopes ≤2.0 pg/mL/mo (P <.0001). The Gleason score (<7 vs ≥7) was the only other significant predictor (hazard ratio 5.4, 95% confidence interval 2.1-13.8, P = .0004).
Conclusion
Clinical recurrence after radical prostatectomy is difficult to predict using established risk factors. We have demonstrated that a NADiA ProsVue PSA slope of ≤2.0 pg/mL/mo after prostatectomy is prognostic for a reduced risk of prostate cancer recurrence and adds predictive power to the established risk factors.

Fifth–Generation Digital Immunoassay for Prostate Specific Antigen by Single Molecule Array Technology.

D.H. Wilson, D.W. Hanlon, G.K. Provuncher, L. Chang, L. Song, P.P. Patel, E.P. Ferrell, H. Lepor,A.W. Partin, D.W. Chan, L.J. Sokoll, C.D. Cheli, R.P. Thiel, D.R. Fournier, and D.C. Duffy
http://dx.doi.org/10.1373/clinchem.2011.169540

Measurement of prostate specific antigen (PSA) in prostate cancer patients following radical prostatectomy (RP) has been hindered by the limit of quantification of available assays. Because radical prostatectomy removes the tissue responsible for PSA production, postsurgical PSA is typically undetectable with current assay methods. Evidence suggests, however, that more sensitive determination of PSA status following RP could improve assessment of patient prognosis and response to treatment and better target secondary therapy for those who may benefit most. We developed an investigational digital immunoassay with a 2–logs–lower limit of quantification than current ultrasensitive third–generation PSA assays. We developed reagents for a bead–based ELISA for use with high–density arrays of femtolitervolume wells. Anti–PSA capture beads with immunocomplexes and associated enzyme labels were singulated within the wells of the arrays and interrogated for the presence of enzymatic product. We characterized analytical performance, compared its accuracy with a commercially available test, and analyzed longitudinal serum samples from a pilot study of 33 RP patients. The assay exhibited a functional sensitivity (20% interassay CV) <0.05 pg/mL, total imprecision <10% from 1 to 50 pg/mL, and excellent agreement with the comparator method. All RP samples were well within the assay measurement capability. PSA concentrations following surgery were found to be predictive of prostate cancer recurrence risk over 5 years. The robust 2–log improvement in limit of quantification relative to current ultrasensitive assays and the validated analytical performance of the assay allow for accurate assessment of PSA status after RP.

Related articles

• EARLY DETECTION OF PROSTATE CANCER: AUA GUIDELINE
   Dror Nir, PhD
  http://pharmaceuticalintelligence.com/2013/05/21/early-detectio…-aua-guideline
• Prostate Cancer Molecular Diagnostic Market – the Players are: SRI Int’l, Genomic Health w/Cleveland Clinic, Myriad Genetics w/UCSF, GenomeDx and BioTheranostics
   Aviva Lev-Ari, PhD, RN
  http://pharmaceuticalintelligence.com/2013/05/21/prostate-cance…iotheranostics/

• EARLY DETECTION OF PROSTATE CANCER: American Urological Association (AUA) GUIDELINE (pharmaceuticalintelligence.com)
• From AUA2013: “Histoscanning”- aided template biopsies for patients with previous negative TRUS biopsies (pharmaceuticalintelligence.com)
• FDA Approves a New Drug for Prostate Cancer (cancerwhattodoorsay.wordpress.com)
• Clinical trial tests targeting prostate cancer treatment (sys-con.com)
• Routine PSA Tests No Longer Recommended – American Urological Association (medicalnewstoday.com)
• Clinical trial tests targeting prostate cancer treatment (hormonetherapymiami.wordpress.com)
• AUA Releases New Clinical Guideline On Prostate Cancer Screening (medicalnewstoday.com)

Risk of prostate cancer in two age groups based on Free PSA as % of Total PSA Catalona W, Partin A, Slawin K, Brawer M, Flanigan R, Patel A, Richie J, deKernion J, Walsh P, Scardino P, Lange P, Subong E, Parson R, Gasior G, Loveland K, Southwick P (1998). “Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial”. JAMA 279 (19) : 1542–7. doi:10.1001/jama.279.19.1542. PMID 9605898. (Photo credit: Wikipedia)

English: Human prostate specific antigen (PSA/KLK3) with bound substrate from complex with antibody (PDB id: 2ZCK) (Photo credit: Wikipedia)

Table 1. Side-effects and effects on recovery of treatments for newly diagnosed prostate cancer. The Prostate Brachytherapy Advisory Group: http://www.prostatebrachytherapyinfo.net (Photo credit: Wikipedia)

00

Share this:

• Click to share on Twitter (Opens in new window)
• Click to share on LinkedIn (Opens in new window)
• Click to share on Facebook (Opens in new window)
• Click to print (Opens in new window)
• Click to email a link to a friend (Opens in new window)

Like this:

Like Loading...

Read Full Post »

The Incentive for “Imaging based cancer patient’ management”

Posted in Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, CANCER BIOLOGY & Innovations in Cancer Therapy, Cell Biology, Signaling & Cell Circuits, FDA Regulatory Affairs, Health Economics and Outcomes Research, HealthCare IT, Imaging-based Cancer Patient Management, International Global Work in Pharmaceutical, Medical Devices R&D Investment, Personalized and Precision Medicine & Genomic Research, Pharmaceutical R&D Investment, Population Health Management, Genetics & Pharmaceutical, Scientist: Career considerations, Statistical Methods for Research Evaluation, Technology Transfer: Biotech and Pharmaceutical, tagged breast cancer, breast cancer mortality, breast cancer screening, breast thermography, Cancer - General, Cancer screening, cancer tumours, Cardiac surgery, Chemotherapy, Clinical trial, Conditions and Diseases, costs of treatment, Diagnosis, early diagnosis, elastography, evidence based medicine, health, health economics, histoscanning, imaging based cancer detection, imaging ultrasound, innovations in cancer detection, Magnetic resonance imaging, mammography, medicine, National Institutes of Health, New England Journal of Medicine, new methods for cancer detection, Proceedings of the National Academy of Sciences of the United States of America, Prostate cancer, Prostate cancer screening, research, science, smart imaging, tissue characterisation, ultrasound based cancer detection, United States on August 27, 2012| 15 Comments »

The Incentive for “Imaging based cancer patient’ management”

Author and Curator: Dror Nir, PhD

• 

Image taken from http://www.breastthermography.com/breast_thermography_mf.htm

It is generally agreed by radiologists and oncologists that in order to provide a comprehensive work-flow that complies with the principles of personalized medicine, future cancer patients’ management will heavily rely on “smart imaging” applications. These could be accompanied by highly sensitive and specific bio-markers, which are expected to be delivered by pharmaceutical companies in the upcoming decade. In the context of this post, smart imaging refers to imaging systems that are enhanced with tissue characterization and computerized image interpretation applications. It is expected that such systems will enable gathering of comprehensive clinical information on cancer tumors, such as location, size and rate of growth.

What is the main incentive for promoting cancer patients’ management based on smart imaging? 

It promises to enable personalized cancer patient management by providing the medical practitioner with a non-invasive and non-destructive tool to detect, stage and follow up cancer tumors in a standardized and reproducible manner. Furthermore, applying smart imaging that provides valuable disease-related information throughout the management pathway of cancer patient will eventually result in reducing the growing burden of health-care costs related to cancer patients’ treatment.

Let’s briefly review the segments that are common to all cancer patients’ pathway: screening, treatment and costs.

 

Screening for cancer: It is well known that one of the important factors in cancer treatment success is the specific disease staging. Often this is dependent on when the patient is diagnosed as a cancer patient. In order to detect cancer as early as possible, i.e. before any symptoms appear, leaders in cancer patients’ management came up with the idea of screening. To date, two screening programs are the most spoken of: the “officially approved and budgeted” breast cancer screening; and the unofficial, but still extremely costly, prostate cancer screening. After 20 years of practice, both are causing serious controversies:

In trend analysis of WHO mortality data base [1], the authors, Autier P, Boniol M, Gavin A and Vatten LJ, argue that breast cancer mortality in neighboring European countries with different levels of screening but similar access to treatment is the same: “The contrast between the time differences in implementation of mammography screening and the similarity in reductions in mortality between the country pairs suggest that screening did not play a direct part in the reductions in breast cancer mortality”.

In prostate cancer mortality at 11 years of follow-up [2],  the authors,Schröder FH et. al. argue regarding prostate cancer patients’ overdiagnosis and overtreatment: “To prevent one death from prostate cancer at 11 years of follow-up, 1055 men would need to be invited for screening and 37 cancers would need to be detected”.

The lobbying campaign (see picture below)  that AdmeTech (http://www.admetech.org/) is conducting in order to raise the USA administration’s awareness and get funding to improve prostate cancer treatment is a tribute to patients’ and practitioners’ frustration.

 

 

 

Treatment: Current state of the art in oncology is characterized by a shift in  the decision-making process from an evidence-based guidelines approach toward personalized medicine. Information gathered from large clinical trials with regard to individual biological cancer characteristics leads to a more comprehensive understanding of cancer.

Quoting from the National cancer institute (http://www.cancer.gov/) website: “Advances accrued over the past decade of cancer research have fundamentally changed the conversations that Americans can have about cancer. Although many still think of a single disease affecting different parts of the body, research tells us through new tools and technologies, massive computing power, and new insights from other fields that cancer is, in fact, a collection of many diseases whose ultimate number, causes, and treatment represent a challenging biomedical puzzle. Yet cancer’s complexity also provides a range of opportunities to confront its many incarnations”.

Personalized medicine, whether it uses cytostatics, hormones, growth inhibitors, monoclonal antibodies, and loco-regional medical devices, proves more efficient, less toxic, less expensive, and creates new opportunities for cancer patients and health care providers, including the medical industry.

To date, at least 50 types of systemic oncological treatments can be offered with much more quality and efficiency through patient selection and treatment outcome prediction.

Figure taken from presentation given by Prof. Jaak Janssens at the INTERVENTIONAL ONCOLOGY SOCIETY meeting held in Brussels in October 2011

For oncologists, recent technological developments in medical imaging-guided tissue acquisition technology (biopsy) create opportunities to provide representative fresh biological materials in a large enough quantity for all kinds of diagnostic tests.

 

Health-care economics: We are living in an era where life expectancy is increasing while national treasuries are over their limits in supporting health care costs. In the USA, of the nation’s 10 most expensive medical conditions, cancer has the highest cost per person. The total cost of treating cancer in the U.S. rose from about $95.5 billion in 2000 to $124.6 billion in 2010, the National Cancer Institute (www.camcer.gov) estimates. The true sum is probably higher as this estimate is based on average costs from 2001-2006, before many expensive treatments came out; quoting from www.usatoday.com : “new drugs often cost $100,000 or more a year. Patients are being put on them sooner in the course of their illness and for a longer time, sometimes for the rest of their lives.”

With such high costs at stake, solutions to reduce the overall cost of cancer patients’ management should be considered. My experience is that introducing smart imaging applications into routine use could contribute to significant savings in the overall cost of cancer patients’ management, by enabling personalized treatment choice and timely monitoring of tumors’ response to treatment.

 

 References

1. 1.      BMJ. 2011 Jul 28;343:d4411. doi: 10.1136/bmj.d4411
2. 2.      (N Engl J Med. 2012 Mar 15;366(11):981-90):

Share this:

• Click to share on Twitter (Opens in new window)
• Click to share on LinkedIn (Opens in new window)
• Click to share on Facebook (Opens in new window)
• Click to print (Opens in new window)
• Click to email a link to a friend (Opens in new window)

Like this:

Like Loading...

Read Full Post »

Prostate Cancers Plunged After USPSTF Guidance, Will It Happen Again?

Posted in CANCER BIOLOGY & Innovations in Cancer Therapy, Cell Biology, Signaling & Cell Circuits, FDA Regulatory Affairs, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, tagged Archives of Internal Medicine, Prostate cancer, Prostate cancer screening, Prostate-specific antigen, PSA, StataCorp, United States Preventive Services Task Force on July 31, 2012| 5 Comments »

Prostate Cancers Plunged After USPSTF Guidance, Will It Happen Again?

Reporter: Aviva Lev-Ari, PhD, RN

• 

Declines in Prostate Cancer Incidence After Changes in Screening Recommendations

David H. Howard, PhD

Arch Intern Med. 2012;():1-2. doi:10.1001/archinternmed.2012.2768

 

On August 5, 2008, the US Preventive Services Task Force (USPSTF) recommended against screening men 75 years or older for prostate cancer.¹ For men younger than 75 years, the USPSTF maintained its previous recommendation: “ . . . the evidence is insufficient to recommend for or against routine screening for prostate cancer. . . ”^2 (p915) (although this recommendation was changed to “do not screen” younger men in the 2011 guidelines). This study evaluates trends in prostate cancer incidence following the release of the 2008 USPSTF recommendation. If the revised recommendation led to a decline in prostate cancer screening rates, there should be a corresponding decline in the incidence of early-stage tumors among men 75 and older relative to trends in the incidence of late-stage tumors and early-stage tumors in younger men.

Methods

I measured trends in prostate cancer incidence rates by age group using the Surveillance, Epidemiology and End Results (SEER) 18 registry data, covering 28% of the US population. The SEER registries collect information on all newly diagnosed cancer cases in their respective catchment areas.

Prostate tumors were identified using International Classification of Diseases for Oncology version 3 code 619. I classified cases by stage at diagnosis using the derived American Joint Committee on Cancer summary stage variable: early (T1 or T2), late (T3 or T4), or unknown. I grouped patients into 3 age categories (30-64 years, 65-74 years, and 75 years and older). I calculated incidence rates per 100 000 persons, standardized within age categories by age (in 5-year age groups), race (white, black, American Indian, or other), and ethnicity (Hispanic or not Hispanic) to the 2009 population. I used an unpaired t test for proportions to assess the significance of differences in rates between years. The data were analyzed in Stata version 11 (StataCorp) statistical software.

 Results

The data included 254 184 prostate cancer cases. There were 198 417 early-stage cases, 34 695 late-stage cases, and 21 072 cases of unknown stage. There were 109 053 cases (all stages) among men aged 30 to 64 years, 91 868 cases among men aged 65 to 74 years, and 53 263 cases among men 75 years and older.

The Figure displays the age and race/ethnicity-adjusted incidence rates of early-stage tumors among men aged 65 to 74 years (the upper line) and 75 years and older (the lower line). The trend lines generally mirror each other, but there is a sudden decrease in the incidence of early-stage tumors among men 75 and older after the release of the revised USPSTF recommendation.

Figure. Trends in the incidence of early-stage prostate tumors by age group. Rates are standardized by 5-year age groups and race/ethnicity to the 2009 population. Source: analysis of Surveillance, Epidemiology and End Results (SEER) 18 registry data. USPSTF indicates US Preventive Services Task Force.

View Large  |  Save Figure  |  Download Slide (.ppt)

Between 2007 and 2009, the adjusted incidence rate for early-stage tumors among men 75 years and older decreased from 443 to 330 per 100 000 (−25.4%; P < .001). The absolute number of cases declined from 8137 to 6162. The incidence of late-stage tumors decreased from 83 to 71 (−14.3%; P < .001), and the incidence of tumors with unknown stage decreased from 124 to 103 (−16.8%; P < .001). The incidence of early-stage tumors among men aged 65 to 74 years decreased from 697 to 591 (−15.2%; P < .001). The incidence of early-stage tumors among men aged 30 to 64 years decreased from 105 to 93 (−11%; P < .001). Incidence trends for all age and stage groups are given in the eTable.

July 25, 2012 — Nick Mulcahy reports in

http://www.medscape.com/viewarticle/768073?src=nldne

In the past, clinicians and the public have heeded the advice of the United States Preventative Services Task Force (USPSTF) about prostate cancer screening, suggests researchpublished online July 23 in the Archives of Internal Medicine.

After the group’s 2008 guidance, which recommended against screening men older than 75 years, the incidence of early-stage disease in older men plunged 25% in the United States.

“There was an immediate decline in the incidence of early-stage prostate cancer tumors among men 75 years and older after the USPSTF recommended against screening this group,” writes author David Howard, PhD, from the Department of Health Policy and Management at Emory University in Atlanta, Georgia.

The incidence of early-stage disease is an indicator of the amount of prostate-specific antigen (PSA) testing in a population, he explained.

Dr. Howard found that from 2007 to 2009, the adjusted incidence rate for early-stage tumors in men 75 years and older decreased from 443 to 330 per 100,000 (−25.4%; P < .001). The absolute number of cases declined from 8137 to 6162.

Dr. Howard used data from the Surveillance, Epidemiology, and End Results (SEER) 18 registry, which collects information on newly diagnosed cancer cases in catchment areas.

He challenges recent results that indicated that there was no change in PSA screening rates from 2005 to 2010 (JAMA. 2012;307:1692-1694). The data source for that study was the National Health Interview Surveys, in which American residents self-report health behaviors and diseases. “Self-reported PSA testing measures have poor sensitivity and specificity,” scolds Dr. Howard.

An immediate question arises from Dr. Howard’s analysis: Will it happen again because of the 2012 USPSTF recommendation against routine testing for all healthy men?

In an unrelated essay (J Clin Oncol. 2012;30:2581-2584), a group of experts assert that the answer is no.

The USPSTF’s “blanket rejection” of the PSA test is “unlikely to influence practice,” according to Sigrid Carlsson, MD, PhD, from the Memorial-Sloan Kettering Cancer Center in New York City and Göteborg University in Sweden, and colleagues. Dr. Carlsson and her fellow experts wrote an essay criticizing the new USPSTF guideline for a number of “very important errors,” as reported by Medscape Medical News.

“PSA testing is not likely to go away,” wrote Dr. Carlsson and coauthors.

Dr. Howard voiced similar thoughts in an email to Medscape Medical News.

“Physicians are probably more willing to discontinue screening older patients. There might be more resistance to discontinuing screening among younger, healthier men,” he said.

But Dr. Howard also said: “I think it will have an impact. There is growing publicity about the problem of ‘overdiagnosis’, which might make physicians and some patients more receptive to the USPSTF recommendation.”

The recently published PIVOT study might also contribute to the way the new guidance is received, noted Dr. Howard. This major randomized controlled trial found that prostatectomy did not improve survival significantly, compared with observation, in men with localized disease. “This research also casts doubt on the benefits of early detection, which may amplify the impact of the USPSTF recommendation,” said Dr. Howard about PIVOT.

Nonetheless, “many men will continue to receive regular PSA tests,” he added.

More Details

In addition to finding that the rate of early-stage prostate cancers dropped among older men after the 2008 recommendation, Dr. Howard found that other indicators of PSA testing also dropped.

The incidence of late-stage tumors decreased by 14.3% (P < .001), and the incidence of tumors of unknown stage decreased by 16.8% (P < .001). The incidence of early-stage tumors in men 65 to 74 years decreased by 15.2% (P < .001); in men 30 to 64 years, the incidence decreased by 11% (P < .001).

Overall, Dr. Howard found that 254,184 prostate cancer cases were newly diagnosed during the study period. There were 198,417 early-stage cases, 34,695 late-stage cases, and 21,072 cases of unknown stage. There were 109,053 cases (all stages) in men 30 to 64 years of age, 91,868 cases in men 65 to 74 years, and 53,263 cases in men 75 years and older.

As noted above, the incidence rate trends turned sharply downward in 2009, after the 2008 USPSTF report.

REFERENCES

METHODS | RESULTS | COMMENT | AUTHOR INFORMATION | REFERENCES

 

1

US Preventive Services Task Force.  Screening for prostate cancer: US Preventive Services Task Force recommendation statement.  Ann Intern Med. 2008;149(3):185-191

2

US Preventive Services Task Force.  Screening for prostate cancer: recommendation and rationale.  Ann Intern Med. 2002;137(11):915-916

3

Prasad SM, Drazer MW, Huo D, Hu JC, Eggener SE. 2008 US Preventive Services Task Force recommendations and prostate cancer screening rates.  JAMA. 2012;307(16):1692-1694

4

Hall HI, Van Den Eeden SK, Tolsma DD,  et al.  Testing for prostate and colorectal cancer: comparison of self-report and medical record audit.  Prev Med. 2004;39(1):27-35

5

Chan EC, Vernon SW, Ahn C, Greisinger A. Do men know that they have had a prostate-specific antigen test? accuracy of self-reports of testing at 2 sites.  Am J Public Health. 2004;94(8):1336-1338

6

Guerra CE, Jacobs SE, Holmes JH, Shea JA. Are physicians discussing prostate cancer screening with their patients and why or why not? a pilot study.  J Gen Intern Med. 2007;22(7):901-907

7

Linder SK, Hawley ST, Cooper CP, Scholl LE, Jibaja-Weiss M, Volk RJ. Primary care physicians’ reported use of pre-screening discussions for prostate cancer screening: a cross-sectional survey.  BMC Fam Pract. 2009;1019

 

Share this:

• Click to share on Twitter (Opens in new window)
• Click to share on LinkedIn (Opens in new window)
• Click to share on Facebook (Opens in new window)
• Click to print (Opens in new window)
• Click to email a link to a friend (Opens in new window)

Like this:

Like Loading...

Read Full Post »

• Follow Blog via Email

  Enter your email address to follow this blog and receive notifications of new posts by email.

  Email Address

  Follow

  Join 9,329 other subscribers

• Recent Posts

  • The Health Care Dossier on Clarivate PLC: How Cortellis Is Changing the Life Sciences Industry April 16, 2024
  • Live Notes from JP Morgan Healthcare Conference Virtual Endpoints Preview: January 8-9 2024 January 16, 2024
  • The Future of AI in Cardiology November 5, 2023
  • Overview of Alzheimer’s Disease and Novel Treatments Targeting Beta-Amyloid Deposits October 7, 2023
  • The Implications and Association of Stair Climbing with Atherosclerotic Cardiovascular Disease (ASCVD) October 6, 2023
  • The Nobel Prize in Physiology or Medicine 2023 October 2, 2023
  • The Current Impact and Future of Technology within Cardiovascular Surgery September 23, 2023
  • The Continued Impact and Possibilities of AI in Medical and Pharmaceutical Industry Practices September 18, 2023
  • Regulatory T cells (Tregs) are important for sperm tolerance and male fertility September 11, 2023
  • ChatGPT Chemistry Assistant for Text Mining and the Prediction of metal–organic framework (MOF) synthesis August 27, 2023

• Archives

  Archives Select Month April 2024  (1) January 2024  (1) November 2023  (1) October 2023  (3) September 2023  (3) August 2023  (2) July 2023  (2) June 2023  (7) May 2023  (4) April 2023  (2) March 2023  (5) February 2023  (2) January 2023  (3) December 2022  (2) October 2022  (6) September 2022  (2) August 2022  (1) July 2022  (3) June 2022  (3) May 2022  (8) April 2022  (10) March 2022  (7) February 2022  (7) January 2022  (3) December 2021  (3) November 2021  (4) October 2021  (11) September 2021  (5) August 2021  (8) July 2021  (21) June 2021  (8) May 2021  (10) April 2021  (8) March 2021  (15) February 2021  (17) January 2021  (20) December 2020  (10) November 2020  (12) October 2020  (26) September 2020  (17) August 2020  (22) July 2020  (27) June 2020  (33) May 2020  (26) April 2020  (42) March 2020  (22) February 2020  (11) January 2020  (7) December 2019  (20) November 2019  (13) October 2019  (11) September 2019  (3) August 2019  (8) July 2019  (25) June 2019  (47) May 2019  (40) April 2019  (27) March 2019  (29) February 2019  (17) January 2019  (50) December 2018  (14) November 2018  (17) October 2018  (18) September 2018  (17) August 2018  (8) July 2018  (20) June 2018  (22) May 2018  (17) April 2018  (12) March 2018  (20) February 2018  (26) January 2018  (16) December 2017  (6) November 2017  (20) October 2017  (13) September 2017  (16) August 2017  (16) July 2017  (19) June 2017  (20) May 2017  (32) April 2017  (21) March 2017  (10) February 2017  (24) January 2017  (21) December 2016  (43) November 2016  (8) October 2016  (40) September 2016  (67) August 2016  (59) July 2016  (75) June 2016  (37) May 2016  (95) April 2016  (152) March 2016  (175) February 2016  (196) January 2016  (139) December 2015  (90) November 2015  (287) October 2015  (237) September 2015  (115) August 2015  (96) July 2015  (63) June 2015  (44) May 2015  (53) April 2015  (76) March 2015  (95) February 2015  (83) January 2015  (75) December 2014  (75) November 2014  (88) October 2014  (135) September 2014  (117) August 2014  (88) July 2014  (88) June 2014  (109) May 2014  (60) April 2014  (85) March 2014  (58) February 2014  (72) January 2014  (107) December 2013  (104) November 2013  (136) October 2013  (62) September 2013  (32) August 2013  (46) July 2013  (74) June 2013  (110) May 2013  (112) April 2013  (86) March 2013  (92) February 2013  (63) January 2013  (63) December 2012  (46) November 2012  (71) October 2012  (84) September 2012  (82) August 2012  (122) July 2012  (59) June 2012  (34) May 2012  (46) April 2012  (2)

• Categories

  Categories Select Category 3D Printing for Medical Application  (234)    3D Plotting Scaffolds  (43)    BioInks  (33)       Biopolymer Blend Open Porous  (17)       Dental Applications  (10)    BioPrinting in Regenerative Medicine  (74)       Cell Level  (14)       MicroEngineering Cell-Tissue & Systems  (30)       Tissue Engineering  (35)    Cardiovascular and Vascular Systems  (29)       Artificial Vascular Structures  (9)       Cardiovascular Tissue  (8)    Drug Development using MultiOrgan Chip  (11)    Drug Development/Formulation using 3D Printing  (8)    MEMS  (16)       Bio-MEMS  (12)    Organ-on-a-Chip  (11)    Programmable Sensors (Carbon Nano Tubes)  (5) 3rd Party IP: Drug DIscovery  (1) 4D Printing and Meta Materials  (9) Academic Publishing  (222)    Key Opinion Leaders in eScientific Publishing – Interviews with  (8) Advanced Drug Manufacturing Technology  (93)    Antimalarial Preparation  (8)    Autologous Cell Therapy  (12)    Automated Cell Processing  (13) Allergy and Infectious Diseases  (12) Alzheimer’s Disease  (160)    Etiology  (77)    Medical Device Therapies for Altzheimer’s Disease  (14)    Pharmacotherapy and Cell Activity  (50) Anticancer Resistance  (28) Art Exhibits on the Human Condition  (1) Art Inspires Science  (3) Artificial Heart  (2) Artificial Intelligence – General  (194)    An executive’s guide to AI  (9)    Artificial Intelligence – Breakthroughs in Theories and Technologies  (94)    Artificial Intelligence Applications in Health Care  (95)       Artificial Intelligence in CANCER  (28)       Artificial Intelligence in Health Care – Tools & Innovations  (55)    Artificial Intelligence in Medicine – Application for Diagnosis  (52)       Artificial intelligence applications for cardiology  (23)          AI-assisted Cardiac MRI  (9)       Artificial Intelligence in Psychiatry  (5)       Deep Learning in Pathology  (14)    Artificial Intelligence in Medicine – Applications in Therapeutics  (50)    ChatGPT, GPT-4  (4)       ChatGPT at LPBI Group  (2)       ChatGPT in Academic Education  (3)    Machine Learning  (48)       Deep Learning  (8)       Natural Language Processing (NLP)  (25)    Machine learning in predicting type 2 diabetes  (2) Auditory and vision  (13) Autism Spectrum Disorders  (10) Autoimmune Inflammatory DIseases  (21)    Crohn’s disease  (5)    Tolerance-inducing Autoimmune Disease Therapeutics  (4)    Ulcerative Colitis  (3) Autophagosome  (3) Bacterial Resistance  (25) Behavior  (26) Behavioral Genetics  (21) Big Data  (79)    Intelligent Information Systems  (48) Bio Instrumentation in Experimental Life Sciences Research  (365)    Analytical Instruments Industry  (5)    Microfuidics  (8) Bio-Ethics  (14) BioBanking  (33) Biodegradable Drug-eluting Material  (7) Bioengineering & reverse engineering design  (42) BioIT: BioInformatics  (143) BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics  (126)    Advanced Computing Platform  (31)       Blockchain Transactions System  (6)          Platform for Content Monetization embedded Content Promotion  (1)    Pancreatic adenocarcinoma classifier  (4)    Simulation Modeling in NGS  (3) Biological Engineering  (41) Biological Networks  (190) Biological Networks, Gene Regulation and Evolution  (474)    Virology  (10) Biomarkers & Medical Diagnostics  (565)    VOC – Volatile Organic Compounds as BioMarkers  (2) Biomedical Measurement Science  (173) BioSimilars  (111) BioTechnology – Venture Creation  (126)    Foundations for supporting Science and Education  (12)    Philanthropy to Academic Institution  (2) BioTechnology – Venture Creation, Venture Capital  (105)    Seeking Talent  (3) BiVAD  (1) Blindness  (6) Bone Disease and Musculoskeletal Disease  (82) Brain Basis of Emotion  (5) Business Career Consideration  (1) Ca2+ triggered activation  (59) Calcium  (19) Calcium Signaling  (68) Calmodulin Kinase and Contraction  (35) Cancer – General  (177) Cancer and Current Therapeutics  (397)    interventional oncology  (42)       Breast Cancer – impalpable breast lesions  (17)       Prostate Cancer: Monitoring vs Treatment  (8) CANCER BIOLOGY & Innovations in Cancer Therapy  (1,092)    Anaerobic Glycolysis  (51)    Cachexia  (18)    Cancer Genomics  (69)       Circulating Tumor Cells (CTC)  (19)          Liquid Biopsy Chip detects an array of metastatic cancer cell markers in blood  (14)             mRNA  (5)          MagSifter chip  (1)       KRAS Mutation  (6)       Li-fraumeni syndrome.  (3)       TP53 – Germline mutations  (5)    cancer metabolism  (20)    Funding Opportunities for Cancer Research  (11)    Genomic Expression  (143)    Glioblastoma  (7)    Hexokinase  (14)    Loss of function gene  (18)    Metabolic Immuno-Oncology  (16)    Metastasis Process  (13)    Methylation  (32)    Microbiome and Responses to Cancer Therapy  (5)    Monoclonal Immunotherapy  (27)    mtDNA  (13)    Oxidative phosphorylation  (56)    Pancreatic cancer  (9)    Pyruvate Kinase  (27)    The NCI Formulary  (1)    tumor microenvironment  (13)    Warburg effect  (50) Cancer Informatics  (93) Cancer Prevention: Research & Programs  (125) Cancer Screening  (102) Cancer Vaccines: Targeting Cancer Genes for Immunotherapy  (25)    Engineering Enhanced Cancer Vaccines  (3) cancer-general  (1) Cardiac and Cardiovascular Surgical Procedures  (321)    Aortic Valve: TAVR, TAVI vs Open Heart Surgery  (87)       Prosthesis-Patient Mismatch (PPM) in TAVI vs SAVR  (2)       TAVI vs Open Heart Surgery  (6)       Transcatheter Aortic Valve Replacement via the Transcarotid Access  (2)       Transcaval TAVR Procedure  (3)       Valve-in-Valve Procedure  (4)    Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias  (17)    BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy  (1)    CABG  (47)    Cancer Surgery of the Heart  (10)    Cardiovascular Fluid Management: algorithms  (1)    Heart Transplant  (15)    Heart-Lung Transplant  (10)    Implantation  (2)    Left Main Coronary Artery Disease (LMCAD)  (3)    Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart  (19)    Mitral Valve: Repair and Replacement  (63)       TMVR – Transcatheter Mitral Valve Repair  (4)    PCI  (104)       Bioresorbable Vascular Scaffold (BVS)  (3)       Invasive FFR for PCI  (2)       Multivessel PCI FFR Guidance  (1)       Robotic-assisted percutaneous coronary intervention  (1)       Stent Retriever in endovascular thrombectomy  (2)    Peripheral Arterial Disease & Peripheral Vascular Surgery  (63)       Abdominal Aorta  (20)       Carotid Artery  (15)       Limb ischemia  (4)       Thoracic Aorta  (16)    Pulmonary Valve Replacement and Repair  (3)    Renal Denervation  (20)    Replacement  (1)    Robotically assisted Cardiothoracic Surgery  (1)    Tricuspid Valve Repair  (7)    Vena Caval Filters: Device for Prevention of Pulmonary Embolism and Thrombosis  (1) Cardiovascular Pharmacogenomics  (169) Cargo  (3) Cell Biology  (320) Cell Biology, Signaling & Cell Circuits  (663)    Apoptosis  (17)    Autophagy-Modulating Proteins  (6)    “Antibody–enzyme conjugates”  (5)    Cell Processing System in Cell Therapy Process Development  (25)    Endoplasmic reticulum  (3)    Enzymatic mechanism underlying the synthesis of adenosine triphosphate (ATP)  (3)    Ubiquitin  (10) Cerebrovascular and Neurodegenerative Diseases  (123)    Stroke  (9) Chemical Biology and its relations to Metabolic Disease  (461)    #BIGAxisSummit  (1)    Gut Microbiome and Obesity  (8) Chemical Genetics  (349) Child and Adolescent Psychiatry  (13) Childhood cancer  (15) Childhood malnutrition  (3) children  (2) Circulating Progenitor Cells  (27)    Bone marrow derived cells  (17)    Endothelial cells  (7)    Umbilical cord cells  (6) Clinical & Translational  (235) Clinical Diagnostics  (216)    Mass automation of plasma proteins  (13) Clinical Genomics  (136) Coagulation Therapy and Internal Bleeding  (83) Cognition  (46) Commercialization  (20) Components and IRB related issues  (4) Computational Biology/Systems and Bioinformatics  (465)    Computational Histopathology  (3)    Meta-analysis of transcriptome data  (9) Conference Coverage with Social Media  (477)    MassBio  (3) coronavirus  (18) COVID-19  (20) CRISPR/Cas9 & Gene Editing  (188)    CRISPR alternative for editing genes without cutting  (14)       CAST – Alternative to CRISPR/Cas9  (3)       Transposon-encoded CRISPR–Cas systems direct RNA-guided DNA integration  (4)    CRISPR applied to Human Germ Line  (10)       Gene Editing Impact on Longevity  (4) CT  (19) Cytokines  (20) Cytoskeleton  (84) Developmental biology  (107) Diabetes Mellitus  (142)    Artificial Pancreas for Type 2 Diabetes  (1)    Artificial Pancreas for Type1 Diabetes  (5)    Gestational diabetes  (2) Diagnostic Immunology  (58) Diagnostics and Lab Tests  (127)    Liquid Biopsy: Circulating Tumor Cells in Urine and Blood  (8) Digital HealthCare – biotech & internet joint ventures  (46) Disease Biology  (333) Disease Biology, Small Molecules in Development of Therapeutic Drugs  (484) DNA repair  (72)    Apoptosis  (12)    Autophagy  (13)    Cell death pathways  (19)    Proteolysis  (8)    Proteosome  (8) Drug Delivery Platform Technology  (156)    Drug Carrier Design  (20)       Medication Remote Compliance Monitoring  (3)    Exosomes: Natural Carriers for siRNA Delivery  (9) Drug Toxicity  (74) Ecosystems & Industrial Concentration in the Medical Device Sector  (172)    Cardiac & Vascular Repair Tools Subsegment  (128)    Exec Compensation in the Cardiac & Vascular Repair Tools Subsegment  (14)    Massachusetts Niche Suppliers and National Leaders  (20) Electronic Health Record  (9) Embryology  (24) Empathy  (6) Endocrine Diseases  (60) Enzyme Induction  (46)    ion-transporting enzyme  (2)    K + -ATPase.  (1)    Na +  (2) Epigenetics and Environmental Factors  (32) Ethics and Leadership  (10) Executive Compensation – Big Pharma  (3) Fat soluble vitamins  (4) FDA  (68) FDA Regulatory Affairs  (355)    FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning – GCP, GLP, ISO 14155  (52)    ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics  (30) Fetal Ultrasound  (2) Fiction and medicine  (5) Frontiers in Cardiology and Cardiovascular Disorders  (920)    Acute Myocardial Infarction  (62)       Cardiogenic Shock  (5)    Anemia in CVD Patients  (6)    Cardio-Oncology  (4)    Cardiomyopathy  (57)    Cardiovascular Research  (187)       Myocardial metabolism, Myocardial ischemia, myocardial perfusion, Myocardial adenine nucleotide metabolism  (64)       Pre-Clinical Animal Model Development  (23)    Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH)  (20)    Cost of Inpatient Stay for Cardiovascular Diagnosis for Admission  (1)    Electrophysiology  (108)       Ablation Procedure vs Drug Therapy  (2)       Arrhythmia Detection with Machine Learning Algorithms  (6)       Cardiotoxic Risks of Immune Checkpoint Inhibitors  (1)       Genomic Analysis of EKG Electrophysiology Genomics  (3)       implantable cardioverter defibrillator (ICD) and External Defibrillation  (1)       implantable pacemaker  (2)       Rare heart rhythm disorders and Long QT syndrome (LQTS)  (6)    Epigenetics and Cardiovascular Risks  (57)    Heart Failure (HF)  (48)       Acute coronary syndrome  (6)       congestive heart failure  (18)    Medical Devices R&D and Inventions  (208)       Assist Devices: LV  (3)       RV  (1)       Stents & Tools  (89)       Valves & Tools  (65)    Origins of Cardiovascular Disease  (419)       Atherogenic Processes & Pathology  (178)       Congenital Heart Disease  (34)          Genetic Mutations in Congenital Heart Disease  (4)       inflammation independent of lipid levels  (12)       Systemic Inflammatory Diseases as CVD Risk  (11)    Pharmacotherapy of Cardiovascular Disease  (353)       HTN  (173)       HTN in Youth  (8)       Resident-cell-based  (43)       Subarachnoid Hemorrhage (SAH)  (1)       Transthyretin amyloid cardiomyopathy (ATTR-CM)  (1)    Spontaneous Coronary Artery Dissection (SCAD)  (6)    Stroke  (14)       endovascular thrombectomy  (5)    Vascular Diseases  (21)       mesenteric ischemia  (3) Future Pandemics Inform-graphics  (1) Gastroenterology  (38) Gene Regulation  (228) Gene Regulation and Evolution  (135) Genetics & Innovations in Treatment  (172) Genetics & Pharmaceutical  (199) Genome Biology  (959)    Exosomes  (24)    Gene Therapy & Gene Editing Development  (38)    mRNA Therapeutics  (17)    Mutagenesis  (26)    Single Cell Genomics  (22)    Single-cell sequencing  (18)    Variation in human protein-coding regions  (32) Genomic Endocrinology  (42) Genomic Testing: Methodology for Diagnosis  (412) Genomics Pharmacy  (38) Global Market of Medical Devices Technology  (2) Global Medical Publishers by Country  (3) Global Partnering & Biotech Investment  (45) GLP  (4) Glycobiology: Biopharmaceutical Production  (15) Glycobiology: Biopharmaceutical Production, Pharmacodynamics and Pharmacokinetics  (27) Health Care System by Country  (49)    AI Models in Healthcare  (8)    Centers for Medicare & Medicaid Services  (8)    Health in Israel  (2)    United States  (24)       Hospital-based Medical Innovations  (8)       Medical Recertification and Maintenance of Certification (MOC)  (1) Health Economics and Outcomes Research  (378)    Women Health  (15)       Heart and Brain Disease in Women  (3) Health Law & Patient Safety  (162)    and Bioethics  (13)    Biotechnology  (11)    Health Law Policy  (12) HealthCare IT  (136) Healthcare Reform  (112)    Accountable Care Organizations  (26)    Affordable Care Act  (29)       Repair  (1)       Repeal ACA  (1)       Replace  (1)    Federal Budget Appropriations  (26)    Healthcare costs and reimbursement  (55)    Indigent Nutrition  (14)    Medicare and Medicaid  (20)    Prescription Drugs Costs  (21)    Skilled Nursing Facilities  (6)    Technology Capital Expenses  (15)    Uninsured and Underinsured  (20) Hematology  (99)    Acute lymphocytic leukemia  (18)    Acute myelocytic leukemia  (21)    Hematopoiesis  (48)    Lymphoma  (21) History and physical exam  (6) Human aging  (27) Human Immune System in Health and in Disease  (237) Human Sensation and Cellular Transduction: Physiology and Therapeutics  (21) Image Processing/Computing  (41) Imaging-based Cancer Patient Management  (116) Immuno-Oncology & Genomics  (126)    mRNA platform in Drug DIscovery  (6) Immunodiagnostics  (128)    Cancer-Immune Interactions  (20)    CNS-Immune Interface  (3)    Neuronal Circuits  (4) Immunology  (114)    Adaptive Immune Response to Biomaterials and Tissue Repair  (10)    Antibody Responses Predict Antigen Exposure  (15)    Cytokine Receptor Structure  (8)    Human Antibody Response  (17)    Human Circulating Antibody Repertoire  (10)    Human Naive B Cell Repertoire  (8)    MHC Repertoires for Antigen Prediction  (8)    Protection Against Autoimmune Disease  (9)    Synthetic Immunology: Hacking Immune Cells  (12) Immunotherapy  (121)    CAR-T  (13)    combination immunotherapies.  (11)    Efficacy of Anti-Tumor T Cells  (11)    Engineering Better T Cells  (7)    Immune Engineering  (13)    Immune Modulatory  (13)    Integrin-targeted Combination Immunotherapy  (5)    Modulating Macrophages in Cancer Immunotherapy  (11)    NK Cell-Based Cancer Immunotherapy  (16)    Synergistic Innate and Adaptive Immunotherapy  (13) Income Disparity  (2) Infectious Disease & New Antibiotic Targets  (162)    Antibiotic resistance  (7)    Viral diseases  (37)       Myocarditis  (1) Infectious Disease Immunodiagnostics  (56)    Virology – Vector-borne DIsease  (17) Inflammasome  (26)    Anti-tumor necrosis factor drugs (TNF inhibitors)  (2) Innovation in Immunology Diagnostics  (107)    Universal Immune Cell Therapies (uICT)  (10) Innovations  (185)    R&D Expenditure  (8) Innovations in Neurophysiology & Neuropsychology  (142)    Age and Life Expectancy  (1)    autism spectrum disorder  (1)    Circadian Rhythm and Sleep  (6)    hNPCs  (1)    Nervous System Function  (2)    Relapsing Multiple Sclerosis  (1) Intellectual Property  (76)    Disputes and Settlements  (9)    IP Valuation Models – Pricing Intangible Assets  (5)    Patent Law in Biotech  (12) Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough  (108) International Global Work in Pharmaceutical  (188) Interventional Oncology: Radiofrequency Ablation, Transarterial Chemoembolization, Microwave Ablation and Irreversible Electroporation (IRE)  (12) Interviews with Scientific Leaders  (302)    Albany Medical Center Prize in Medicine and Biomedical Research  (1)    Annual Breakthrough Prize  (2)    Annual Lewis S. Rosenstiel Award  (1)    Awards in Cardiology and Cardiovascular Medicine  (4)    CEOs of Biotech Companies  (2)    Gerald D Aurbach Award for Outstanding Translational Research  (1)    Interviews with Key Opinion Leaders (KOLs)  (7)    James Prize in Science and Technology Integration  (1)    Jessie Stevenson Kovalenko Medal – Medical Sciences  (1)    Lemelson-MIT Prize  (1)    Life Sciences Breakthrough Prize  (3)    Mosteller Statistician of the Year Award  (1)    Mourning the Loss of a Scientific Leader  (2)    National Academy of Sciences AWARDS  (2)    Nobel Prize Winners  (21)    Noble Prize (Not Nobel Prize)  (1)    Paul Marks Prize for Cancer Research  (1)    Russ Prize recognizes bioengineering achievements worldwide  (1)    The Dan David Prize  (5)    Warren Alpert Foundation Prize Recipients  (3)    Wolf Prize  (1)    Wolf Prize in Medicine  (1)    women in science  (3) Investment in Technological Breakthrough  (60) Ionic Transporters Na+  (25) IP Development by LPBI Group Team  (10) IP Development by LPBI Group Team & Other Organizations  (7) ISO 14155  (3) Joint Venture – SBH & M3DP: SOP and Arrangements  (1) Justice & Law  (1) K  (15) Lab-on-a-chip  (2) Landscape  (1) Lasers and photonics  (18)    Midrange IR spectroscopy  (1) Law and Medicine Conflicts  (14) Leadership, Power, Social Interlocking Connections  (13) Lipid metabolism  (109)    Fatty acids  (38)    Lipids  (38)    PCSK9 Inhibitor Therapy  (19) Lipidomics  (11) Liposome  (4) Liver & Digestive Diseases Research  (120) LPBI Group, e-Scientific Media, DFP, R&D-M3DP, R&D-Drug Discovery, US Patents: SOPs and Team Management  (129)    Award Nominations  (5)    BioMed e-Books e-Series by LPBI Group  (8)    Feedback from Investors: LPBI Portfolio of Five Businesses  (2)    LPBI Group Founder – Aviva Lev-Ari  (22)    PhD  (1)    RN  (1) LPBI Management  (15) Massachusetts Academy of Sciences (MAS)    (2) Materials Science & Engineering  (37)    Organic BioElectronics  (2) Math  (13)    Great Discoveries  (7) Mechanical Assist Devices: LVAD  (4) Medical and Population Genetics  (191) Medical Devices R&D Investment  (239)    21st Century Cures Act  (2)    CE Mark & Global Regulatory Affairs: process management and strategic planning – GCP  (13)    Rhythm management device hardware: dual-chamber pacemakers  (1)       Systolic HTN  (1) Medical Imaging Technology  (55) Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound  (160)    Circumferential-Intravascular-Radioluminescence-Photoacoustic-Imaging (CIRPI)  (3)    Echocardiography  (2)    MRI  (17)    Noninvasive Diagnostic Fractional Flow Reserve (FFR) CT  (5)    Ultra Sound  (7) Melatonin & Circadian Regulation  (9) memory loss  (1) Metabolism  (236)    Biochemical pathways  (142)       Enzymes and isoenzymes  (72)          Dehydrogenase  (16)          Kinase  (28)          Phosphatase  (9)          Phosphorylase  (22)          tyrosine decarboxylases  (3)    Inosine nucleotides  (9)    Leloir pathway  (6)    microbiome  (7)    Pentose monophosphate shunt  (14)    Pyridine nucleotides  (28)       Pyridine nucleotide transhydrogenase  (7) Metabolomics  (318) Methods  (37) Mg++  (10) Microbiologial genetics  (34) Microbiology  (67)    Virology  (14) Micronutrients  (16) Microvesicle  (7) Microwave Ablation and Irreversible Electroporation (IRE)  (1) Mobile Healthcare  (4) Molecular Genetics & Pharmaceutical  (375)    Organoids  (3) Monoclonal antibody therapy  (13) Mutant Gene Expression  (42) Myocardial adenine nucleotide metabolism  (6) Myocardial Ischemia  (26) Myocardial Metabolism  (36) Na-K transport  (40) Na-K-ATPase  (27) Nanotechnology for Drug Delivery  (97) Nephrology  (46) Nephrology & Regenerative medicine  (9) Neurodegenerative Diseases  (88)    hNPCs  (3)    MS  (5) Neurohumoral Transmission  (67)    Ca2+ triggered activation  (20)    Calmodulin  (13)    Parkinson’s disease dyskinesia levodopa  (3)    PKC  (13)    Synaptic vesicle  (20) Neurological Diseases  (121) Neuroscience  (126) Next Generation Sequencing (NGS)  (25)    Nanopore sequencing  (1) NIH Common Fund  (1) Nitric Oxide in Health and Disease  (136) Nuclear Medicine  (11) Nutrigenomics  (68) Nutrition  (194)    Nutritional Supplements: Atherogenesis, lipid metabolism  (49) Nutrition and Phytochemistry  (61)    Minerals in Medicine  (4)    Plant extract  (22) Nutrition Disorders  (30) Nutritional Supplements: Atherogenesis  (31) Obesity  (18) Oligonucleotide Therapeutics & Delivery  (7) Oncolytic virus & OncoViro-Therapy  (21)    Synthetic Virology  (1) Organ-on-a-Chip & 3D Printing in Life Sciences  (7) Pain: Etiology, Genetics & Innovations in Treatment  (24) Parasitology  (5)    Malaria  (4)    Tropical diseases  (1) Patents  (34) Patient Experience  (64)    Art therapy  (1)    Hospital reputation  (7)    Humor  (1)    Music therapy  (2)    Pain Alleviation  (7)    Patient Outlook  (28)    Reputation of Interventionist  (4)    Support Staff  (13)    Supportive therapies  (6)       laughfter  (1)    Surgical Procedure  (7) Patient Experience: Personal Memories of Invasive Medical Intervantion  (30) Patient’s Voice: Personal Experience with Invasive Medical Procedures  (18) Perioperative Statins at Noncardiac Surgery  (2) Personal Health Applications: Tech Innovations serves HealhCare  (36) Personalized and Precision Medicine & Genomic Research  (717)    Longevity  (2)    New Drug Approval  (5)    Patient-centered Medicine  (35)       cell-based therapy  (8)       stem cell biology and patient-specific  (6)    Personalized Medicine Coalition  (8)    Precision Cancer Medicine  (18) Phagophore  (2) Pharmaceutical Analytics  (259)    Pharmacologic toxicities  (61) Pharmaceutical Discovery  (107)    Rapid automation of plasma protein pools  (16) Pharmaceutical Drug Discovery  (198)    Drug Development Process  (55)       Drug Discovery Chemistry  (29)    drug repurposing  (10) Pharmaceutical Industry Competitive Intelligence  (339)    Pharmacovigilance  (6)    Value-based Drug Pricing  (8) Pharmaceutical R&D Informatics  (43) Pharmaceutical R&D Investment  (297) Pharmacodynamics and Pharmacokinetics  (24) Pharmacogenomics  (157) Photography Collection  (1) Physics  (12) Placenta  (7) Population genetics  (25) Population Health Management  (192)    Evolution of Biology Through Culture  (14)    U.S. Employment-to-Population Ratio  (8) Population Health Management, Genetics & Pharmaceutical  (623)    COVID-19  (155)       Biomarkers: Inflammation  (36)       Cancer Researchers Fighting COVID-19  (14)       COVID-19 effects on Human Heart  (15)       COVID-19: Pandemic Surgery Guidance  (19)       Economic Impact of Coronavirus Pandemic  (41)       number of asymptomatic infections  (27)       Treatment Protocols for COVID-19  (62)    SARS-CoV-2  (138)       Coronavirus Gene Expression  (65)          SARS-CoV-2 circulating variants   (14)          SARS-CoV-2 Viral Variants  (18)       Glycosylation and its Role in SARS-CoV-2 Viral Pathogenesis  (2)       Immune-Mediation (independent immunopathology: lung and reticuloendothelial system)  (29)       Mechanisms of infection by SARS-CoV-2  (21)       SAR-Cov-2 a vasculotropic (blood vessels) RNA Virus  (35)          SARS-COV2 Hijacking the Complement and Coagulation Systems  (19)       Seasonality & Environmental Factors in Resurgence  (26)       Serology tests for coronavirus antibodies  (44)       T-cell response to SARS-CoV-2 infection  (14)       Vaccinology  (51)          Mechanism of Thrombosis with AZ & J&J COVID-19 Vaccines  (5)       Virtual Drug Molecule Screening targeting SAR-CoV-2 proteins  (8)    Virus Infective Acute Respiratory Syndrome: SARS-CoV  (92) Population Health Management, Nutrition and Phytochemistry  (151) Preimplantation Genetic Diagnosis and Reproductive Genomics  (13) Protein-energy malnutrition  (12) Proteomics  (360)    Amino acids  (52)    Proteins  (134) Pulmonary diseases  (16)    Lung and pulmonology  (15) Pulmonary pathology  (8) Radio Frequency (RF)-based Surgical Solutions  (2) REAL TIME Conference Coverage Twitter’s Hashtags and Handles per Presentation/session  (31) Regenerative Biology and Medicine  (92) Regulated Clinical Trials: Design, Methods, Components and IRB related issues  (265) Reproductive Andrology, Embryology, Genomic Endocrinology, Preimplantation Genetic Diagnosis and Reproductive Genomics  (113) Reproductive Biology & Bio Instrumentation  (78) RNA Biology  (81)    RNA interference (RNAi) therapeutic  (4) RNA Biology, Cancer and Therapeutics  (62) RVAD  (1) SBIR, SBA, NIH, NSF  (3) Schizophrenia  (16) Scientific & Biotech Conferences: Press Coverage  (174) Scientific Publishing  (607)    Curation  (584)       Curation methodology  (40)       De novo synthesis  (16)       Dialectic  (17)       Discovery process  (71)       Evolutionary cognition  (52)       Experimental validation  (90)       Explanatory  (91)       Historical relevance  (71)       Technology Advance Assessment of  (69)       Theoretic convergence  (27)    Open Access Journals  (37) Scientist: Career considerations  (196)    Big Data & Analytics  (17)    Data Science  (13)    Women in Life Sciences  (11) Scoop.it  (19) Sensors & Analytics  (18) Sepsis  (2) Severe Autism  (3) Signaling  (100)    Phosphorylation  (42)    S-nitrosylation  (13)    Ubiquitinylation  (33) Signaling & Cell Circuits  (129) single cell sequencing  (2) Small Molecules in Development of Therapeutic Drugs  (70) Social Development  (15) Specialized 3D BioPrinters (Cornea  (1) Statistical Methods for Research Evaluation  (137) Stem Cells for Regenerative Medicine  (175)    Cardiac muscle regeneration  (19)    Competition in regenerative stem cell science  (17)    Human neural progenitor cells  (7)    Skeletal muscle regeneration  (9) STORM  (2) Stress Disorders  (19) Substance Abuse  (4) Systemic Inflammatory Response Related Disorders  (160)    Inflammatory Pathophysiology  (8) Technology Transfer: Biotech and Pharmaceutical  (353) therapeutics  (3) Tissue Engineering and Regenerative Medicine  (22) Tissue Microenvironment  (4) Transarterial Chemoembolization  (2) Transcriptomics  (43) Transformative Technologies in Healthcare  (14) Translational Science  (226)    Best evidence  (52)    Bias measurement tools  (2)    Evidence-based decision-making  (27)    Inferential analysis  (25)    Intra-rater error  (1)    Quality Assurance  (8)    Random Error  (2)    Systematic Error (Bias)  (6)    Total error  (2)    Translational Effectiveness  (49)    Translational Research  (89) Trends in Global Economy  (6) Uncategorized  (1,009) Unfolded Protein Response (UPR)  (6) US and Global Economy: Trends and Findings  (9) Venture Capital  (45)    Income Geographic Distribution  (2)    Institutional Capital Raised by Female Founders  (6) virology  (9) Vision  (7) Voices of Patients and Healthcare Providers  (21) Water Transporters  (8) Wearable Tech + Digital Health  (4) Anemia  (21) Neutropenia  (8) Neutrophilia  (9) Platelet count disorder  (9) Folate and B12  (7) Iron deficiency  (5) Myelodysplasia  (12) Myelofibrosis  (10)

• Meta

  • Log in
  • Entries feed
  • Comments feed
  • WordPress.org

• • 2012pharmaceutical
  • Amandeep Kaur
  • Aashir Awan, Phd
  • Abhisar Anand
  • Adina Hazan
  • Alan F. Kaul, PharmD., MS, MBA, FCCP
  • alexcrystal6
  • anamikasarkar
  • apreconasia
  • aptubman
  • Arav Gandhi
  • aviralvatsa
  • David Orchard-Webb, PhD
  • danutdaagmailcom
  • Demet Sag, Ph.D., CRA, GCP
  • Dror Nir
  • dsmolyar
  • Ethan Coomber
  • evelinacohn
  • Gail S Thornton
  • Irina Robu
  • jayzmit48
  • jdpmd
  • jshertok
  • kellyperlman
  • Ed Kislauskis
  • larryhbern
  • Madison Davis
  • marzankhan
  • megbaker58
  • ofermar2020
  • Dr. Pati
  • pkandala
  • ritusaxena
  • Rick Mandahl
  • sjwilliamspa
  • Srinivas Sriram
  • stuartlpbi
  • Dr. Sudipta Saha
  • tildabarliya
  • zraviv06
  • zs22