Active surveillance in intermediate-risk prostate cancer with PSA 10–20 ng/mL: pathological outcome analysis of a population-level database

BACKGROUND: Active surveillance (AS) is generally recognized as the preferred option for men with low-risk prostate cancer. Current guidelines use prostate-specific antigen (PSA) of 10–20 ng/mL or low-volume biopsy Gleason grade group (GG) 2 as features that, in part, define the favorable intermediate-risk disease and suggest that AS may be considered for some men in this risk category. METHODS: We identified 26,548 men initially managed with AS aged <80 years, with clinically localized prostate cancer (cT1-2cN0M0), PSA ≤ 20 ng/mL, biopsy GG ≤ 2 with percent positive cores ≤33% and who converted to treatment with radical prostatectomy from the surveillance, epidemiology, and end results prostate with the watchful waiting database. Multivariable logistic regression was performed to determine predictors of adverse pathology at RP according to PSA level (<10 vs 10–20 ng/mL) and GG (1 vs 2). RESULTS: Of 1731 men with GG 1 disease and PSA 10–20 ng/mL, 382 (22.1%) harbored adverse pathology compared to 2340 (28%) of 8,367 men with GG 2 and a PSA < 10 ng/mL who had adverse pathology at RP. On multivariable analysis, the odds of harboring adverse pathology with a PSA 10–20 ng/mL (odds ratio [OR] 1.87, 95% confidence interval [CI] 1.71–2.05, p < 0.001) was less than that of GG 2 (OR 2.56, 95%CI 2.40–2.73, p < 0.001) after adjustment. CONCLUSIONS: Our results support extending AS criteria more permissively to carefully selected men with PSA 10–20 ng/mL and GG 1 disease.