EQUIPOISE: EQUivalence In Prostate cancer treatment: surgery Or radiotherapy? An Intention-to-treat Survival analysis from real-world Evidence.

Abstract

Purpose: To compare cancer-specific and overall survival between a surgery-based strategy and radiotherapy plus androgen deprivation (RT + ADT) in intermediate- and high-risk localized prostate cancer, using contemporary real-world data from a Latin American public health system.

Methods: Using the state-wide cancer registry of São Paulo, Brazil, we studied men with intermediate- or high-risk localized prostate cancer diagnosed in 2014-2023. Treatment was assigned by initial modality (intention-to-treat). The primary outcome was cancer-specific survival (CSS), with overall survival (OS) secondary. Groups were compared after 1:1 propensity-score matching, with weighting and per-protocol sensitivity analyses.

Results: Of 21,292 patients, matching yielded 4263 pairs (all standardized mean differences below 0.10). CSS did not differ between RT + ADT and surgery [hazard ratio 0.87, 95% CI 0.58-1.29, p = 0.48 (intermediate); 1.00, 95% CI 0.78-1.27, p = 0.98 (high)]. At 5 years, CSS with surgery versus RT + ADT was 98.0% versus 96.6% (intermediate) and 94.9% versus 92.9% (high); OS was 92.6% versus 84.6% and 87.5% versus 82.7%. The crude OS advantage of surgery did not persist after matching (p = 0.10; p = 0.33). Additional therapy was given to 20.2% of operated men, rising to 48.9% in pN1 disease.

Conclusions: Surgery and RT + ADT showed similar cancer-specific and overall survival after adjustment, and surgery frequently entailed multimodal therapy. Both can be presented as alternative therapeutic options in shared decision-making.