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 <0.2 ng/mL/mL, a Gleason score of ≤3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow‐up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1‐year repeat biopsies, and outcomes after radical prostatectomy (RP). RESULTS Patients were included between December 2006 and July 2008. The median (25–75th percentile) follow‐up after diagnosis was 1.02 (0.6–1.5) years. The 2‐year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow‐up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score 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.