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editorial
. 2023 Oct 16;42(2):245–255. doi: 10.5534/wjmh.230160

Table 2. Randomized controlled trials on focal therapy for localized prostate cancer.

Title ClinicalTrials.gov Identifier Country Experimental comparator Active comparator Primary outcome
Comparative healthcare research outcomes of novel surgery in prostate cancer (IP4-CHRONOS): a prospective, multi-centre therapeutic phase II parallel randomised control trial [24] NCT04049747 United Kingdom HIFU or cryotherapy Whole gland treatment Progression-free survival
Evaluation of HIFU in treatment of localized prostate cancer and of recurrence after radiotherapy (HIFI) [46] NCT04307056 France HIFU RP Recurrence-free survival
Phase 3, multicenter, randomized study, evaluating the efficacy and tolerability of focused HIFU (high intensity focused ultrasound) therapy compared to active surveillance in patients with significant low risk prostate cancer (HIFUSA) [47] NCT03531099 France HIFU AS Patient proportion who needed radical treatment
Focal prostate ablation versus radical prostatectomy (FARP) [48] NCT03668652 Norway HIFU RP Treatment failure
Partial prostate ablation versus radical prostatectomy [49] ISRCTN99760303 United Kingdom HIFU or IRE RP Treatment failure
Prostate cancer IRE study (PRIS): a randomized controlled trial comparing focal therapy to radical treatment in localized prostate cancer [25] NCT05513443 Sweden IRE RP (PRIS1) Urinary continence (PRIS1)
RT (PRIS2) Irritative urinary symptoms (PRIS2)

This table presents a compilation of ongoing RCTs comparing FT with radical treatments such as RP or RT, as well as AS. It is important to note that unlike in the past, the comparators for FT are now primarily whole-gland treatments instead of AS. HIFU followed by cryotherapy and IRE are the main energy modalities used in current RCTs.

RCT: randomized control trial, FT: focal therapy, RP: radical prostatectomy, RT: radiotherapy, AS: active surveillance, HIFU: high-intensity focused ultrasound, IRE: irreversible electroporation.