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.