Active surveillance for localized prostate cancer. Nationwide, observational study

PURPOSE: The objective of this study was to investigate nationwide survival outcomes in men with localized prostate cancer managed on active surveillance.

MATERIAL AND METHODS: 936 men with localized prostate cancer initiated active surveillance in Denmark in 2002-2012. Kaplan-Meier estimated curative treatment-free-, hormonal therapy-free-, castration-resistant prostate cancer-free- and cause-specific survival were calculated.

RESULTS: Two hundred and twenty-three men were classified with very low-risk prostate cancer, 436 men with low-risk prostate cancer, 259 men with intermediate-risk prostate cancer (87% had favorable intermediate-risk prostate cancer), and 18 men with high-risk prostate cancer. The median follow-up was 7.5 years (IQR 6.1-9.1 years). Kaplan-Meier estimated 10-year curative treatment-free survival was 62.8% (95% CI 59.1-66.3%), 10-year hormonal therapy-free survival was 92.2 (95% CI 89.2-94.4%), 10-year castration-resistant prostate cancer-free survival was 97.2% (95% CI 95.3-98.4%) and the 10-year cause-specific survival was 99.6% (95% CI 98.6-99.9%). Compared to men with low-risk prostate cancer, men with intermediate-risk prostate cancer had a higher curative treatment-free survival (69% vs. 56%, p = 0.008), a lower hormonal therapy-free survival (88% vs. 95%, p = 0.005), and similar castration-resistant prostate cancer-free survival (95% vs. 99%, p = 0.17).

CONCLUSION: In this nationwide cohort the 10-year cause-specific survival was similar to prospective active surveillance cohorts. Our study supports the use of active surveillance for men with localized prostate cancer - including men with favorable intermediate-risk characteristics.