Video Lectures
State-of-the-industry video lectures by leading urology experts
Latest Videos

ORLANDO, FL USA (UroToday.com) - Dr. Neal Shore presented an abstract on a multi-institutional study evaluating the safety and tolerability of long-term treatment (≥ 24 months) and also reported on the efficacy at 56% overall survival (OS) events of study COU-AA-302. In study COU-AA-302, 1 088 patients were randomized 1:1 to abiraterone (AA) 1000 mg + prednisone (P) 5 mg po BID vs placebo + P. “Co-primary” end points were radiographic progression-free survival (rPFS) and OS. Kaplan-Meier was used to estimate the 95% confidence interval (CI) of the end points and median times. Moreover, efficacy analysis and post hoc analysis of adverse events (AEs) was performed at the pre-specified third interim analysis (IA3).

auaAt IA3, the median follow-up was 27.1 months. rPFS, (HR=0.53 [95% CI], (0.45-0.62), p < 0.0001), and OS (HR=0.79 [95%CI], (0.66-0.96), p = 0.0151), were improved over P; the latter did not reach the pre-specified efficacy boundary (p = 0.0035). All reported secondary end points favored the AA arm of the study. In regards to adverse effects, grade 3/4 AEs (AA + P vs P) were reported as: hypokalemia (3% vs 2%); hypertension (4% vs 3%); increase in alanine aminotransferase (6% vs 1%); and also increase in aspartate aminotransferase (3% vs 1%). Dr. Shore showed the date illustrating that prolonged exposure to AA + P was safe and well tolerated vs P alone among most men. Moreover AA + P did not clinically show any relevant increase in the incidence rate of grade 3/4 AEs with ≥ 24 months drug exposure. The percentage of patients who came off the study due to an AE was reported as 8% (AA) vs 6% (P).

Abiraterone acetate is a selective androgen biosynthesis inhibitor that prolongs OS in patients with mCRPC and is approved for use in this population. This study shows that the updated IA3 of COU-AA-302 causes delay in progression and prolongation of life with a favorable safety profile, including patients who were treated for more than 24 months with AA + P or P.

Presented by Neal D. Shore, MD at the American Urological Association (AUA) Annual Meeting - May 16 - 21, 2014 - Orlando, Florida USA

Myrtle Beach, SC USA

Written by Reza Mehrazin, MD, medical writer for UroToday.com

 

Clinical Trials
Searchable data base of currently enrolling clinical trials
Calendar
Upcoming urology industry events
August 28-31, 2018 / ICS 2018
International Continence Society 2018
September 1-3, 2018 / European Society for Medical Oncology Academy 2018
European Society for Medical Oncology Academy 2018
September 5-8, 2018 / Fairmont Hotel, Chicago, IL
92nd Annual Meeting of the North Central Section of the AUA
Journals
Print publications focusing on urological cancer treatments through original commentary & articles
Everyday Urology Volume 3 Issue 1

Everyday Urology™ - Oncology Insights

From the Editor

PCAN cover

Prostate Cancer and Prostatic Diseases

From the Editor