Abstract
Background: Focal therapy (FT) represents a minimally invasive option for selected patients with localized prostate cancer (PCa), aiming to achieve oncological control while preserving functional outcomes. Despite its increasing adoption, long-term effi-cacy data remain limited, and predictors of recurrence are not well defined. Methods: We conducted a retrospective multicenter cohort study of 209 men with histologically confirmed unifocal or oligo-focal (≤3 lesions) PCa treated with FT (high-intensity focused ultrasound [HIFU], vascular-targeted photodynamic therapy [VTP], cryotherapy, or transurethral ultrasound ablation [TULSA]) between 2019 and 2024 at three German centers. Clinical, histopathological, treatment-related, and multipar-ametric MRI (mpMRI) parameters were prospectively collected in a REDCap-based registry. Recurrence-free survival (RFS) and progression-free survival (PFS) were analyzed using Kaplan–Meier estimates, and Cox regression was applied to identify independent predictors. Results: Median patient age was 66 years, and median PSA was 6.4 ng/mL. ISUP grade distribution was 58% grade 1, 29% grade 2, and 13% grade ≥3. Treatment modalities comprised HIFU (43%), VTP (35%), cryotherapy (12%), and TULSA (10%). After a median follow-up of 1.73 years, 40% of patients developed recurrence and 15% showed histologic progression. RFS varied by treatment modality (HIFU: 2.26 years; VTP: 1.73 years; cryotherapy: 0.75 years; TULSA: not reached; p = 0.001). Median PFS was 4.7 years. Suspicious baseline mpMRI (PI-RADS 4–5) was associated with shorter RFS. Suspicious follow-up mpMRI strongly predicted both recurrence (RFS 1.1 vs. 2.96 years, p < 0.001) and progression (PFS 1.8 vs. 4.7 years, p = 0.004). In multivariate analysis, suspicious follow-up mpMRI was the only independent predictor of recurrence (HR 2.07, 95% CI 1.24–3.45, p = 0.005). Conclusions: In this multicenter registry analysis, recurrence after FT was frequent, affecting 40% of patients within two years. mpMRI findings before and especially af-ter treatment emerged as the strongest predictors of oncological failure, underscor-ing the central role of standardized imaging in patient selection and surveillance. Pro-spective studies with longer follow-up and centralized radiologic review are needed to refine FT protocols and optimize patient outcomes.
