EAU 2014 - Protocol based versus non-protocol based discontinuation in the Prostate Cancer Research International: Active Surveillance (PRIAS) study - Session Highlights

STOCKHOLM, SWEDEN (UroToday.com) - For men with PCa on active surveillance (AS), PSA, DRE, and surveillance prostate biopsies have all been used to trigger intervention. However, non-protocol driven triggers of AS cessation, such as patient anxiety, remain poorly understood. Dr. Bokhorst and colleagues attempted to quantify the burden of and identify the risk factors for non-protocol based AS discontinuation. The Prostate cancer Research International: Active Surveillance (PRIAS) cohort, which has enrolled 3 659 men with low-risk PCa (defined as: PSA ≤ 10, clinical stage T1-T2, PSA density ≤ 0.2, Gleason 3+3, and ≤ 2 positive cores), was used for analysis. Per AS protocol, men underwent PSA, DRE, and repeat biopsies at regular intervals. Intervention was recommended for disease progression (defined as clinical stage ≥ T3, Gleason score > 3+3, > 2 cores with PCa, and PSADT ≤ 3 years), and men discontinuing AS were divided into protocol and non-protocol based (anxiety, patient request, other/unknown) categories.

eauAt a median follow-up of 1.2 years (range 0.2-7.1 years), 1 054 men (28.8%) discontinued AS. Median therapy-free survival was 4.6 yrs. Seven hundred eighty-eight (74.8%), 126 (12%), and 140 (13.3%) men discontinued AS for protocol, non-protocol, and other/unknown non-protocol based reasons, respectively. The majority (60%) of non-protocol based discontinuation took place in the first year following diagnosis, and non-protocol based discontinuation rates were highest in the Netherlands and France (±30% versus ±15%). Men discontinuing in the first year for non-protocol based reasons more often had a PSADT of 0-3 years (57.7% versus 25.4% for men not discontinuing AS).

In conclusion, 1-in-4 men discontinue AS for non-protocol based reasons, most within the first year. That rate is even lower among Swedish men (approx. 1-in-5), as presented by Dr. Stacey Loeb at a concurrent poster session. Most protocol-based AS discontinuation in the first year occurs because of a rising PSA. There is significant geographic variation in the rate of non-protocol based AS discontinuation.

Increased patient counseling and reassurance during the first year of AS could help reduce the rate of non-protocol based discontinuation.

Presented by L.P. Bokhorst at the 29th Annual European Association of Urology (EAU) Congress - April 11 - 15, 2014 - Stockholmsmässan - Stockholm, Sweden

The Erasmus MC, Department of Urology, Rotterdam (NE)

Written by Jeffrey J. Tomaszewski, MD, medical writer for UroToday.com