Metastatic Castration-Resistant Prostate Cancer: 14-Year Real-World Sipuleucel-T Outcomes in Urology

Background Sipuleucel-T, approved for metastatic castration-resistant prostate cancer (mCRPC) in 2010, improves survival, but real-world outcomes data are limited. We compared baseline characteristics and real-world overall survival (rwOS) of patients treated with and without sipuleucel-T for mCRPC. Methods This multicenter, retrospective observational study analyzed electronic medical records from United States community urology clinics. Men aged ≥ 18 years diagnosed with mCRPC between January 2010 and May 2019 were divided into 2 groups based on whether they received sipuleucel-T. Propensity score matching (PSM) was used to balance the cohorts by age, race, region, prostate-specific antigen (PSA) level, and Gleason score. Results Among 11 265 patients, 47% received sipuleucel-T. They were younger, had lower PSA levels, and better performance scores than those who did not receive it. Median follow-up was 3 years for treated and 1 year for untreated patients. Sipuleucel-T recipients had markedly better 5-year survival rates (28% vs 12%) and lived a median of 20 months longer (44 vs 24 months; P  < .001). Black/African American patients had the highest 5-year survival (24%) compared with White (20%) or other groups (17%). After PSM, the median rwOS was 43 months with sipuleucel-T and 25 months without it, with an 18-month survival advantage (hazard ratio 1.66; 95% CI 1.54–1.78). Conclusions Sipuleucel-T was associated with significantly improved mCRPC survival in real-world settings, especially among Black/African American patients. Findings are subject to limitations, including selection bias and unmeasured confounding, but reinforce the therapeutic and life-prolonging benefit of sipuleucel-T.