Focal Therapy for Prostate Cancer: A Treatment Option Reserved for the Ideal Candi-date?

Objectives: To evaluate outcomes of FT (HIFU or cryotherapy) in prostate cancer (PCa) patients who do not meet the ideal focal therapy candidate profile, assessing whether expanding selection criteria beyond traditional parameters is safe. Materials and methods: A retrospective analysis was performed on 282 patients treated with FT for ISUP 1 and 2 PCa at a single European center (2009-2020). Patients were categorized into three groups: G1 (ideal candidates: single lesion ≤12mm, favorable biopsy features), G2 (ISUP 1 with minor deviations), and G3 (ISUP 2 with multiple lesions, larger tumor size, or positive cores outside the target zone). A secondary exploratory analysis compared ISUP 2 patients fully meeting criteria versus those with one deviating feature. Multivariable regression with propensity score matching was applied. Results: Overall recurrence occurred in 187 patients (66%): 77% in G1, 60% in G2, and 77% in G3. No significant differences were observed between G1 and G3 regarding infield recurrence-free survival, clinically significant infield recurrence-free survival, or outfield recurrence-free survival (all p>0.05). In the secondary analysis, lesion size ≥12mm was the only feature associated with worse infield recurrence-free survival (p=0.04) and clinically significant infield recurrence-free survival (p=0.001). Multivariate Cox regression confirmed lesion size as an independent predictor (HR: 1.21; 95% CI: 1.05-1.40; p=0.01). Conclusions: Expanding FT selection criteria to include selected ISUP 2 patients with features outside traditional parameters appears safe. These preliminary findings highlight the need for multicenter studies to validate these results.