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

Decreased Sleep Associated With Lower Testosterone Levels

MedicalResearch.com Interview with:
Kristen L. Knutson, PhD Associate Professor Center for Circadian and Sleep Medicine Department of Neurology Northwestern University Feinberg School of Medicine Chicago, IL  60611​Premal Patel, MD, PGY-5
Urology
University of Manitoba

MedicalResearch.com: What is the background for this study? What are the main findings? What should readers take away from your report?

Response: Within the literature there has only been small experimental studies which looked at impaired sleep and testosterone. To our knowledge, there has been no study that has evaluated sleep and testosterone using a population dataset. We utilized the National Health and Nutrition Examination Survey to assess the association of sleep with serum testosterone. NHANES examines a nationally representative sample of about ~5000 persons each year.

After performing a multivariate linear regression of numerous variables within the NHANES database (age, marital status, prior co-morbidities, number of hours of sleep, etc…) we found that a reduction in the number of hours slept, increasing body mass index and increasing age were associated with lower testosterone levels.

Given that this is a cross-sectional analysis, we are unable to provide causality of this relationship but we do feel it is important to counsel patients with low testosterone about the importance of living a healthy lifestyle which includes a well-balanced diet, exercise and sufficient sleep.

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