Active Surveillance for Screen-detected Low- and Intermediate-risk Prostate Cancer: Extended Follow-up up to 25 Years in the GÖTEBORG-1 Trial.

[BACKGROUND AND OBJECTIVE] Active surveillance (AS) is used to postpone or avoid surgery or radiotherapy for prostate cancer (PC). While the risk of PC-related death remains low for patients deferring treatment, follow-up data have previously been limited to 15 yr. Since many men outlive this timeframe, studying long-term outcomes is crucial.

[METHODS] We included 488 men with screen-detected PC in the GÖTEBORG-1 screening trial managed with AS, of whom 251 were at a very low risk, 129 at a low risk, and 108 at an intermediate risk. Prostate-specific antigen (PSA) testing was performed every 6-12 mo, and repeated biopsies were indicated if there were signs of clinical progression. Treatment was recommended upon progression (PSA, grade, or stage). Kaplan-Meier analyses were performed for treatment-free, failure-free, and PC-specific survival, measuring time from diagnosis to an event or the last follow-up.

[KEY FINDINGS AND LIMITATIONS] During a median follow-up of 18 yr, a total of 232 men discontinued AS, 81 experienced failure, and 14 died from PC. The treatment-free survival rate at 22 yr was 38% for the entire cohort . At 19 yr, treatment-free survival rates were 55% for very-low-risk, 35% for low-risk, and 30% for intermediate-risk PC. The failure-free survival rate at 22 yr for all men was 68%, and at 19 yr, the rates were 85% for very-low-risk, 74% for low-risk, and 55% for intermediate-risk cases. The PC-specific survival rate at 25 yr for the entire cohort was 94%. At 24 yr, these rates were 99% for very-low-risk, 92% for low-risk, and 85% for intermediate-risk PC. The overall survival rate at 25 yr for all men was 32%, and at 24 yr, the rates were 38% for very-low-risk, 34% for low-risk, and 22% for intermediate-risk PC. The limitation was no predefined AS protocol.

[CONCLUSIONS AND CLINICAL IMPLICATIONS] This study confirms a low risk of PC death with a median follow-up of 18 yr. The risk of failure increased over time, highlighting the need for life-long monitoring. Providing men information about this risk is important.