Patients and methods
prostate
RECURRENCE, CANCER PROGRESSION, PROSTATE, PROSTATE
This controlled, prospective, non-randomized, phase 2 clinical study was carried out in a single European institution between December 2016 and October 2021. Follow-up is still ongoing. All patients gave written informed consent and were extensively informed about established treatment recommendations of RP or RT. The local ethical board approved the study (2019-14595). All patients received mpMRI of the prostate, followed by mpMRI-ultrasound (US)-fusion prostate biopsy of suspicious lesions with a score of ≥ 3 on the Prostate Imaging-Reporting and Data System (PI-RADS)Follow-up protocol included PSA blood tests every three months during the first 2 years after HIFU treatment. At first and second year after HIFU treatment mpMRI and MRI-US fusion biopsies were conducted. AE after treatment were documented, using standard Clavien-Dindo classification. Pre-therapeutic diagnostic procedures, HIFU treatment and follow-up protocols were conducted at the same center. As part of the study protocol, we set up a goal of maximum 20% progression to more aggressive treatments, as this is a reasonable goal to achieve benefits compared to progression risk of Active Surveillance (AS) and based on recommendations by expert consensus statements to define a good focal therapy center [As a unique exception from other centers, we strictly excluded focal HIFU retreatments in our protocol [First, pre-interventional patient characteristics such as age at intervention, PSA level, prostate volume, HIFU therapy (hemi-ablation vs. focal ablation), PI-RADS classification, Gleason grading, number of positive cores in the targeted biopsy cores and number of positive cores in the systematic biopsy cores were described and stratified according to cancer recurrence at follow-up. Failure free survival (FFS), defined as freedom from any further intervention (e.g., RP or RT) due to cancer progression, was the primary outcome of the study. Secondary outcomes included total PSA levels, PSA nadir, area of recurrence diagnosed in mpMRI as part of follow-up and AE.Statistical analysis was performed using IBM SPSS Statistics Version 27 (Armonk, NY: IBM Corp.). Descriptive statistics were reported as frequencies and proportions, continuous variables were presented as medians ± interquartile range (IQR, 25–75). Continuous variables were compared using the Mann–Whitney U test. FFS was demonstrated by Kaplan–Meier curves.