This study evaluated the outcomes of focal therapy (FT) for prostate cancer (PCa) in patients who did not meet the ideal candidate criteria. A total of 282 patients who underwent high-intensity focused ultrasound (HIFU) or cryotherapy for ISUP 1-2 PCa at a European center from 2009 to 2018 were analyzed. Patients were divided into three groups: Group 1 (G1) consisting of ideal candidates, Group 2 (G2) with ISUP 1, and Group 3 (G3) with ISUP 2 but not ideal candidates based on the inclusion criteria. A sub-analysis focused on ISUP 2 patients, comparing G1 with those having only one exclusion criterion. The study used Inverse Probability of Treatment Weighting (IPTW) to compare recurrence-free survival (RFS), treatment-free survival (TFS), and progression-free survival (PFS) between groups.
The median follow-up period was 75 months, and 66% of patients experienced recurrence. However, there were no significant differences in recurrence rates between the groups. G2 had higher RFS and TFS compared to G1 and G3, with RFS of 68 months for G2 compared to 18 months for G1 and 34 months for G3. No differences were observed in PFS across the groups. In the sub-analysis of ISUP 2 patients, there were no significant differences in outcomes between G1 and the other subgroups.
The findings suggest that expanding the FT inclusion criteria to include patients who do not meet the ideal candidate profile can be both safe and acceptable. This approach allows more patients to benefit from FT without compromising outcomes. The study advocates for further multicenter research to validate these results and assess the long-term impact of expanding FT inclusion criteria.