Genetic Variants Help Identify Men At Highest Risk of Prostate Cancer

MedicalResearch.com Interview with:

Fredrick R. Schumacher, PhD, MPH. Associate Professor, Department of Population & Quantitative Health Sciences Case Western Reserve University Cleveland

Dr. Schumacher

Fredrick R. Schumacher, PhD, MPH.
Associate Professor, Department of Population & Quantitative Health Sciences
Case Western Reserve University
Cleveland

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Our study examines the genetic underpinnings of prostate cancer initiation using technology to test variants across the genome. Our study focused on men of European ancestry and included over 80,000 men with prostate cancer and 60,000 men without disease. We discovered 63 novel genetic variants associated with prostate cancer risk, which increases our knowledge of prostate cancer genetic risk factors by more than 60%.

A genetic risk score created from the combination of 163 new and known prostate cancer risk variants revealed men with the highest genetic risk score are nearly seven times more likely to develop disease compared to the average man. Additionally, men with the lowest genetic risk score have a 85% risk reduction of developing prostate cancer compared to the average. Lastly, these new discoveries uncover several biological mechanisms involved in the initiation of prostate cancer.

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bpMRI Can Be Used to Improve Prostate Cancer Risk

MedicalResearch.com Interview with:

Lars Boesen MD PhD Department of Urology Herlev Gentofte University Hospital Herlev

Dr. Boessen

Dr. Lars Boesen MD PhD
Department of Urology
Herlev Hospital

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The current standard of care in prostate cancer diagnosis includes untargeted transrectal ultrasound-guided biopsies for all biopsy-naïve men with clinically suspicion of prostate cancer. However, this strategy that practically has remained unchanged for decades has limited diagnostic accuracy as significant cancers are missed or under-graded and insignificant cancers are unintendedly detected by the random sampling leading to possible overtreatment.

Multiparametric MRI in the diagnosis of prostate cancer has been studied extensively in recent years and has improved detection, localization, staging and risk stratification. It has been suggested that if multiparametric MRIs were used as a triage test prior to biopsies, a significant proportion of men might safely avoid prostate biopsies and the diagnostic ratio of significant vs. insignificant cancer could be improved compared to performing standard biopsies in all men. However, multiparametric MRIs are generally time-consuming (~40 min scan time), expensive and include intravenous contrast media. This reduces its feasibility for widespread clinical implementation in larger patient populations in the western community with its high PCa prevalence.

The development of a simpler and faster (~15 min) biparametric MRI protocol using less scan sequences and circumvents intravenous contrast-media seems to preserve adequate diagnostic accuracy in a detection setting and could facilitate dissemination of prostate MRI as a triage test before any biopsy.

Here we present a large prospective study that assesses the diagnostic accuracy of a novel biparametric MRI to rule out significant prostate cancer in N=1020 biopsy-naive men with clinically suspicion of prostate cancer.

We found that a low suspicion biparametric MRI had a very high negative predictive value (97%) for ruling out significant cancer on confirmatory biopsies. Furthermore, bpMRI suspicion scores were strongly associated with prostate cancer detection rates and restricting biopsies (targeted plus standard) to men with suspicious biparametric MRIs meant 30% could avoid prostate biopsies, improved significant prostate cancer diagnosis by 11%, and reduced insignificant prostate cancer diagnosis by 40% compared to our current diagnostic approach – standard biopsies for all men with clinically suspicion of prostate cancer.  Continue reading

What Happened to Prostate Cancer Screening and Treatment After PSA Guidelines Changed?

MedicalResearch.com Interview with:

James T. Kearns, MD Clinical Fellow, Department of Urology University of Washington School of Medicine Seattle, WA 

Dr. Kearns

James T. Kearns, MD
Clinical Fellow, Department of Urology
University of Washington School of Medicine
Seattle, WA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The effects of the USPSTF recommendation against prostate cancer screening had not been fully characterized among a younger population, particularly with respect to downstream effects such as prostate biopsy, prostate cancer diagnosis, and treatment for prostate cancer.

We found that PSA testing decreased in the years surrounding the USPSTF recommendation, but we also found a larger proportionate decrease in prostate biopsy, prostate cancer diagnosis, and use of surgery or radiation for the treatment of prostate cancer.

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Prostate Cancer: ERLEADA (apalutamide) Delayed Metastases While Not Reducing Quality of Life

MedicalResearch.com Interview with:

Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM

Dr. Saad

Dr. Fred Saad, MD FRCS
Professor and Chief of Urology
Director of GU Oncology
Raymond Garneau Chair in Prostate Cancer
University of Montreal Hospital Center (CHUM)
Director, Prostate Cancer Research , Montreal Cancer Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patient Reported Outcomes (PRO) data from the Phase 3 SPARTAN study showed adding ERLEADA (apalutamide) to androgen deprivation therapy (ADT) for patients with nmCRPC who were asymptomatic and well, did not worsen or cause detriment to HRQoL when compared to the placebo.The percent of patients who felt “quite a bit” or “very much” bothered was low (<2–6 percent of patients in the apalutamide group and 0–6 percent of those in the placebo group), suggesting that ERLEADA treatment was generally well-tolerated. This outcome, coupled with the efficacy results seen in SPARTAN, suggest that apalutamide can be given to patients at risk of metastasis without worry about compounded side effects or negative HRQoL..

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Apalutamide (Erleada™) Extended Metastasis-Free Survival in Resistant Prostate Cancer

MedicalResearch.com Interview with:

Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM

Dr. Saad

Dr. Fred Saad, MD FRCS
Full Professor and Chief of Urologic Oncology, CHUM;
Medical Director of Interdisciplinary Urologic Oncology Group, CHUM;
Department of Surgery/Faculty of Medicine;
Institut du cancer de Montréal/CRCHUM

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The SPARTAN study was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluated ERLEADA (apalutamide), a next-generation androgen signaling inhibitor, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA (PSA doubling time ≤10 months). The post-hoc analysis presented at the American Urological Association (AUA) 2018 annual meeting showed in patients who received the treatment apalutamide while receiving continuous androgen deprivation therapy (ADT) significantly decreased the risk of PSA progression by 94 percent compared with the placebo group. Continue reading

Automated Bone Scan Index Correlates with Survival in Metastatic Prostate Cancer

MedicalResearch.com Interview with:

Andrew J. Armstrong, MD ScM FACP Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology Associate Director for Clinical Research in Genitourinary Oncology Duke Cancer Institute Divisions of Medical Oncology and Urology Duke University

Dr. Armstrong

Andrew J. Armstrong, MD ScM FACP
Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology
Associate Director for Clinical Research in Genitourinary Oncology
Duke Cancer Institute
Divisions of Medical Oncology and Urology
Duke University

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Men with prostate cancer commonly develop bone metastases and undergo nuclear medicine bone scans. However, these scans are non-quantitative, and disease burden has been challenging to assess over time and to relate to clinical outcomes.

We developed a software program and measurement called the automated bone scan index that essentially reads a standard of care nuclear bone scan, provides a quantitative metric, and demonstrate in a phase 3 trial that this aBSI is highly associated with clinical outcomes including survival, time to symptomatic progression, and prostate cancer specific survival.

We accomplished this within a prospective phase 3 international trial of men with metastatic hormone resistant prostate cancer who were followed over a long period of time.  All bone scans were read and measured using the aBSI at baseline, and we found that the aBSI was highly prognostic.  This work validates prior smaller phase 2 BSI studies, and demonstrates both the feasibility and clinical utility for incorporating the aBSI into clinical practice to provide this important prognostic information to patients and providers.

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USPSTF: Men 70 and Older Should Not Be Screened for Prostate Cancer

MedicalResearch.com Interview with:

Alex Krist, M.D., M.P.H Professor of family medicine and population health Virginia Commonwealth University and Active clinician and teacher at the Fairfax Family Practice residency

Dr. Krist

Alex Krist, M.D., M.P.H
Professor of family medicine and population health
Virginia Commonwealth University and
Active clinician and teacher at the Fairfax Family Practice residency

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Prostate cancer is one of the most common cancers to affect men. However, the decision about whether to be screened is complex and personal. The U.S. Preventive Services Task Force reviewed the latest research on the benefits and harms of screening for prostate cancer using PSA-based testing, as well as evidence on treatment.

We found that men who are 55 to 69 years old should discuss the benefits and harms of screening with their doctor, so they can make the best choice for themselves based on their values and individual circumstances. Men age 70 and older should not be screened, as the benefits of screening diminish as men age and the harms are greater.

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Which Cancers Cost The Most To Treat?

MedicalResearch.com Interview with:

Matthew P. Banegas, PhD, MPH Center for Health Research Kaiser Permanente

Dr. Banegas

Matthew P. Banegas, PhD, MPH
Center for Health Research
Kaiser Permanente

MedicalResearch.com: What is the background for this study?

Response: Despite a large body of research on cancer care costs, we observed a significant evidence gap. Namely, while about one-half of cancer diagnoses in the U.S. occur among people under age 65, it can be difficult to find good data on the costs of care for this population. That’s because most of the current literature on cancer care costs is based on SEER Medicare data, which are limited to Medicare fee-for-service beneficiaries.

At a time of rising costs and an ever-increasing number of new therapies, we felt it was important to improve our understanding of cancer costs for U.S. adults of all ages. We examined medical care costs for the four most common types of cancer in the United States: breast, colorectal, lung, and prostate cancer.

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MRI-Guided Prostate Biopsy Improves Precision Diagnosis of Cancer

MedicalResearch.com Interview with:

Veeru Kasivisvanathan MBBS BSc MRCS MSc PGCert Lead for CPD, Division of Surgery and Interventional Science, UCL Academic Section Committee, British Association of Urological Surgeons Twitter: @veerukasi PRECISION Study Coordinator https://clinicaltrials.gov/ct2/show/NCT02380027  

Dr. Kasivisvanathan

Veeru Kasivisvanathan MBBS BSc MRCS MSc PGCert
Lead for CPD, Division of Surgery and Interventional Science, UCL
Academic Section Committee, British Association of Urological Surgeons
Twitter: @veerukasi
PRECISION Study Coordinator
https://clinicaltrials.gov/ct2/show/NCT02380027  

MedicalResearch.com: What is the background for this study? What are the main findings? 

  • We knew that there were limitations in the standard of care pathway for the diagnosis of prostate cancer, TRUS biopsy which missed harmful cancers and over diagnosed harmless cancers.
  • Emerging reports in the literature showed that using an alternative diagnostic pathway, MRI and MRI-targeted biopsy, showed promising prostate cancer detection rates
  • In 2012 we set out in an international working group to design a study that could change clinical practice and replace the standard of care with a pathway involving MRI 

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YONSA (abiraterone acetate) In Metastatic Castration-Resistant Prostate Cancer

MedicalResearch.com Interview with:

https://www.churchillpharma.com/

Paul Nemeth, Ph.D.
Sr. Vice President, Regulatory Affairs, Clinical Development & Quality Assurance
Churchill Pharmaceuticals LLC
King of Prussia, PA 19406


MedicalResearch.com: What is the background for this study?

Response: In the STAAR study, 53 patients with metastatic castration-resistant prostate cancer (mCRPC) were randomized to receive YONSA, an abiraterone acetate fine particle formulation 500 mg once daily in combination with 4 mg of methylpresnisolone twice daily or 1,000 mg daily of the originator abiraterone acetate (OAA) in combination with 5 mg of prednisone twice daily for a period of 84 days.  Previous studies in healthy volunteers under fasted conditions had shown that single oral doses of 500 mg of YONSA are bioequivalent to single oral doses of 1,000 mg OAA and that a background of 4 mg of methylprednisolone twice daily on a single oral dose of 500 mg of YONSA results in the same extent of absorption as a background of 5 mg of prednisone twice daily on a single oral dose of 1,000 mg of OAA.  Continue reading