Long-term Results of Active Surveillance in the Göteborg Randomized, Population-based Prostate Cancer Screening Trial.

Active surveillance (AS) has become a well-accepted and widely used treatment strategy.

To assess the long-term safety of AS for men with screen-detected prostate cancer (PCa).

All men with screen-detected PCa who had very low-, low-, or intermediate-risk PCa and were managed with AS (January 1, 1995 to December 31, 2014) in the Göteborg screening trial.

Prostate-specific antigen tests every 3-12 mo, rebiopsies in cases of clinical progression, and every 2-3 yr in men with stable disease. Triggers for intervention were disease progression (prostate-specific antigen, grade, and/or stage) or patient initiative.

Treatment-free, failure-free, PCa-specific, and overall survival. The Kaplan-Meier method and Cox proportional hazards models were used.

Four-hundred and seventy-four men were managed with AS (median age at diagnosis 66.0 yr, median follow-up 8.0 yr). Two-hundred and two men discontinued AS and initiated treatment. The 10-yr and 15-yr treatment-free survival was 47% and 34%, respectively. The hazard ratio for the treatment for low- and intermediate-risk PCa, compared with very low risk, was 1.4 (95% confidence interval [CI] 1.01-1.94) and 1.6 (95% CI 1.13-2.25). Fifty-four men failed AS. The 10-yr and 15-year failure-free survival was 87% and 72%, respectively. These estimates were 94% and 88% for the very low-risk group, 85% and 77% for the low-risk group, and 73% and 40% for the intermediate-risk group. The hazard ratio for failure for low- and intermediate-risk PCa, compared with very low-risk, was 2.2 (95% CI 1.05-4.47) and 4.8 (95% CI 2.44-9.33). Six men died from PCa and none had very low-risk PCa. The 10-yr and 15-yr PCa-specific survival was 99.5% and 96%, respectively. These estimates were 100% for the very low-risk group, 100% and 94% for the low-risk group, and 98% and 90% for the intermediate-risk group. No predefined protocol was used.

AS is safe for men with very low-risk PCa, but for men with low- and intermediate-risk PCa, AS carries a risk of missing the possibility of being able to cure the cancer. It is questionable whether men who are not in the lowest tumor risk group and who have a long remaining life expectancy are suitable candidates for this strategy.

Long-term results from this study indicate that some men will miss their chance of cure with active surveillance and it is questionable whether active surveillance is a suitable strategy for men who are not in the lowest tumor risk group and who have a very long remaining life expectancy.

European urology. 2016 Apr 15 [Epub ahead of print]

Rebecka Arnsrud Godtman, Erik Holmberg, Ali Khatami, Carl-Gustaf Pihl, Johan Stranne, Jonas Hugosson

Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Sahlgrenska University Hospital, Göteborg, Sweden. Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden., Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Sahlgrenska University Hospital, Göteborg, Sweden., Department of Pathology, Institute of Biomedicine, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden., Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Sahlgrenska University Hospital, Göteborg, Sweden., Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Göteborg, Sweden.

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