MedicalResearch.com Interview with:
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..
MedicalResearch.com: What should readers take away from your report?
Response: This is the first report on HRQoL associated with a novel treatment that has been shown to significantly delay metastases and prolong metastasis-free and symptomatic progression-free survival in this patient population. Patient reported outcomes data are gaining importance as healthcare systems place greater emphasis on the patient’s experience with the treatment.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: As we move prostate cancer care from acute to chronic in nature, Patient Reported Outcomes data should become standard across treatments. Future clinical trials in prostate cancer should include similar outcomes measures so we can best compare and contrast overall treatment success.
Citation: AUA 2018
For easy reference, here is the abstract: https://www.jurology.com/article/S0022-5347(18)40981-0/fulltext
Patient Reported Outcomes (PROs) in SPARTAN, a Phase 3, Double-Blind, Randomized Study of Apalutamide(APA) Plus Androgen Deprivation Therapy (ADT) vs Placebo Plus ADT in Men With Nonmetastatic Castration-Resistant Prostate Cancer
Volume 17, Issue 2, Pages e1070–e1071
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