Focal Prostate Ablation Versus Radical Prostatectomy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical); Procedure: Radical prostatectomy

• Registration Number: NCT03668652
• Lead Sponsor: Oslo University Hospital

Brief Summary

This study aims to compare the treatment results of HIFU and Radical prostatectomy.

Detailed Description

The FARP randomized control study will compare focal ablation of prostate using High Intensity Focused Ultrasound (HIFU) applied by FocalOne® or TULSA® device versus Radical Prostatectomy (RP) in patients with unilateral, intermediate risk prostate cancer.

Study Timeline

• Study Start: 2017-09-30
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-29
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 213

Inclusion Criteria

• Positive MRI (PIRAD 3-5) and biopsy proven unilateral prostate cancer classified as ISUP 1 (with cancer core length > 5mm) or ISUP 2-3 (any length) not eligible to active surveillance or watchful waiting
• PSA ≤ 20 ng/ml
• Treatment naive patients with localized prostate cancer (stage ≤ T2b)

Exclusion Criteria

• Clinical stage T> 2b
• Metastatic lymph node on imaging
• Patients already treated for Pca (hormone therapy, EBRT)
• Patients with contra-indications to MRI
• Patients with active inflammatory bowel disease or previous rectal fistula
• History of previous pelvic radiotherapy
• History of bladder cancer
• History of bladder neck or urethral stricture
• Urogenital infection in progress
• Allergy to latex or gadolinium
• Patients on life support or suffering form unstable neurological diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focal prostate cancer treatment by HIFU	Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)	Patients with target lesion distance \< 30 mm from the rectum will be treated with High Intensity Focused Ultrasound (HIFU) applied by FocalOne HIFU device and patients with lesion \> 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO.
Radical Prostatectomy	Radical prostatectomy	Robot assisted laparoscopic radical prostatectomy or open retro-pubic radical prostatectomy will be performed using validated radical prostatectomy technique. Nerve sparing surgery on side of cancer free prostate lobe will be performed and type of nerve sparing procedure will be specified.

Primary Outcome Measures

Name	Time	Method
Treatment failure.	At 36 months from the treatment date.	Treatment failure in focal ablation arm is classified as the need for secondary whole gland treatment such as radical prostatectomy or EBRT due to detection of ISUP \> 3 in treated and/or untreated areas on follow up prostate biopsy, or development of metastases on imaging.; Treatment failure in the radical prostatectomy arm is classified as PSA \> 0.2 ng/ml after surgery.

Secondary Outcome Measures

Name	Time	Method
Focal ablation failure.	Within 36 months from the treatment date.	Focal ablation failure is classified as presence of Pca ISUP 1 ( \> 5 mm) and/or ISUP 2-3 (any length) on follow up biopsies of the treated prostate zone.
Total re-ablation rate	Within 36 months from the treatment date.	Secondary HIFU ablation was allowed if control biopsies revealed prostate cancer ISUP 1 ( \> 5 mm) and/or ISUP 2-3) in treated or untreated areas.
Diagnostic failure.	Within 36 months from the treatment date.	Diagnostic failure is classified as clinically significant cancer on control biopsy in the untreated area.
Cancer specific and all-cause mortality.	Within 36 months from the treatment date.	Cause of the mortality will be evaluated and registered.
Difference in metastasis-free and overall survival.	Within 36 months years from the treatment date.	Whole body MRI or PET CT will be performed if suspicion on metastases.
Difference in urinary continence between focal ablation and radical prostatectomy.	Within 36 months from the treatment date.	Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire for the evaluation of continence will be used.; Difference in pad free urinary continence and difference in number of pads needed per day.; Difference in urinary incontinens defined as (full continence= 0 pads/day; security pad or mild incontinence = 1pad/day; moderate incontinence = 2pads/day and severe incontinence \> 2pads/day).
Difference in erectile function between focal ablation and radical prostatectomy.	Within 36 months from the treatment date.	International Index of Erectile Function (IIEF-5) questionnaire for the evaluation erectile function will be used.; A score of 1-5 is awarded to each of the 5 questions. Change in total score will be measured between the baseline and most recent follow-up visit.
Difference in quality of life between focal ablation and radical prostatectomy.	Within 36 months from the treatment date.	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) for the evaluation of quality of life between focal ablation and radical prostatectomy will be used.
Difference in adverse events related to both treatments.	Within 36 months from the treatment date	All adverse events will be registered prospectively according to Clavien-Dindo classification.

Trial Locations

Locations (1)

Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet; 🇳🇴 Oslo, Norway