FOCS-24: An integrated oncologic–functional endpoint and its preoperative nomogram after focal therapy for localized prostate cancer

BACKGROUND AND OBJECTIVE: Focal therapy (FT) seeks to balance prostate cancer (PCa) control with preservation of urinary and sexual function, yet most studies report these outcomes separately. We developed FOCS-24, a composite endpoint capturing full oncologic and functional recovery at 24 months after FT for PCa, and created a preoperative nomogram estimating its probability. METHODS: From 2021 to 2025, 324 men underwent primary FT (cryoablation or HIFU) at a tertiary cancer center. FOCS-24 required fulfilment of: PSA kinetics consistent with biochemical control (Phoenix definition), absence of retreatment/salvage therapy, pad-free continence, maintenance of normal urinary function-defined as the absence of newly developed clinically significant urinary symptoms throughout follow-up, and recovery of erectile function (IIEF-5 ≥ 17 or effective pharmacologic support). Men with ISUP > 2 or receiving neoadjuvant/adjuvant ADT were excluded from model development to preserve a homogeneous risk spectrum for model derivation, leaving 205 evaluable cases. Logistic regression identified predictors. Discrimination, calibration and decision-curve analysis assessed model performance. RESULTS: FOCS-24 was achieved by 30/205 men (14.6%). Younger age and posterior tumor location showed the most consistent pattern with complete recovery. The nomogram incorporated age, PSA density, PI-RADS lesion size, percentage of positive biopsy cores and axial location. The model achieved an AUC of 0.76 with favorable derivation-set calibration metrics. Limitations include low number of composite events and restriction to cryotherapy and HIFU. CONCLUSIONS: FOCS-24 provides a rigorous multidomain definition of complete oncologic and functional recovery after FT. External validation across centers and energy platforms is required before clinical implementation.