Focal Prostate Ablation Versus Radical Prostatectomy (FARP)

March 29, 2025 updated by: Eduard Baco, Oslo University Hospital

A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0514
        • Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Radical prostatectomy

Prostatectomy arm:

Robot assisted or open retropubic prostatectomy
Experimental: Focal prostate cancer treatment by HIFU
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 localized > 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO device.
Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)

HIFU arm:

Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure.
Time Frame: 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.
At 36 months from the treatment date.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer specific and all-cause mortality.
Time Frame: Within 36 months from the treatment date.
Cause of the mortality will be evaluated and registered.
Within 36 months from the treatment date.
Focal ablation failure.
Time Frame: 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.
Within 36 months from the treatment date.
Total re-ablation rate
Time Frame: 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.
Within 36 months from the treatment date.
Diagnostic failure.
Time Frame: Within 36 months from the treatment date.
Diagnostic failure is classified as clinically significant cancer on control biopsy in the untreated area.
Within 36 months from the treatment date.
Difference in metastasis-free and overall survival.
Time Frame: Within 36 months years from the treatment date.
Whole body MRI or PET CT will be performed if suspicion on metastases.
Within 36 months years from the treatment date.
Difference in urinary continence between focal ablation and radical prostatectomy.
Time Frame: 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).
Within 36 months from the treatment date.
Difference in erectile function between focal ablation and radical prostatectomy.
Time Frame: 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.
Within 36 months from the treatment date.
Difference in quality of life between focal ablation and radical prostatectomy.
Time Frame: 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.
Within 36 months from the treatment date.
Difference in adverse events related to both treatments.
Time Frame: Within 36 months from the treatment date
All adverse events will be registered prospectively according to Clavien-Dindo classification.
Within 36 months from the treatment date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Eduard Baco, MD, PhD, Prof. assoc., Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2017

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data generated during this study will be evaluated at Oslo University Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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