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

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.

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.

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.

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.