Short‐term outcomes of the prospective multicentre ‘Prostate Cancer Research International: Active Surveillance’ study

Abstract

Study Type – Therapy (prospective cohort)Level of Evidence 2b OBJECTIVE To evaluate the short‐term outcomes of the prospective international Prostate Cancer Research International: Active Surveillance (‘PRIAS’) study (Dutch Trial Register NTR1718), as active surveillance (AS) for early prostate cancer might provide a partial solution to the current overtreatment dilemma in this disease. PATIENTS AND METHODS The first 500 (of >950) participants with asymptomatic T1c/T2 prostate cancer, with a prostate‐specific antigen (PSA) level of ≤10.0 ng/mL, a PSA density of 6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0–10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re‐biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of >6. CONCLUSION AS seems feasible, but mortality outcomes are unknown. A strict follow‐up protocol including standard 1‐year repeat biopsies resulted in a quarter of men stopping AS after 2 years.