Long-term Outcomes in Men with Stable PSA During 5-α Reductase Inhibitor Therapy After Negative Prostate Biopsy:...

Evidence on long-term outcomes after a negative biopsy, particularly prostate cancer mortality, remains limited, and optimal follow-up strategies are unclear. This nationwide population-based study assessed whether prostate-specific antigen (PSA) decline or stability during 5-α reductase inhibitor (5-ARI) therapy after a negative biopsy identifies men at very low risk of prostate cancer and prostate cancer death. Using Prostate Cancer data Base Sweden (PCBaSe Xtend), we identified men with longitudinal PSA and biopsy data who had at least one negative prostate biopsy between 2007 and 2018 and who initiated 5-ARI therapy with defined exposure and adherence criteria. PSA change during the first 2 yr of treatment was evaluated using PSA velocity and classified as stable or increasing. Follow-up started 2 yr after treatment initiation. Among 1248 men, 901 had stable PSA and 347 had increasing PSA. After 10 yr, the cumulative incidence proportion of prostate cancer was 8.3% (95% confidence interval [CI] = 6.0-12%) in men with stable PSA and 18% (95% CI = 13-24%) in men with increasing PSA; most cancers in men with stable PSA were low grade. Prostate cancer mortality was very low among men with stable PSA (standardized mortality ratio [SMR] = 0.19; 95% CI = 0.04-0.56) and higher in men with increasing PSA (SMR = 1.20; 95% CI = 0.52-2.37. Stable PSA during 5-ARI therapy after a negative biopsy was associated with very low prostate cancer mortality; whether this should influence PSA surveillance intensity requires further study.