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Completed

NCT Number: NCT03668652

Focal Prostate Ablation Versus Radical Prostatectomy

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet

Oslo, 0514, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)

Device

HIFU arm:

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

radical prostatectomy

Procedure

Prostatectomy arm:

Robot assisted or open retropubic prostatectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Cancer specific and all-cause mortality.

    Time frame: Within 36 months from the treatment date.

    Cause of the mortality will be evaluated and registered.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy

Acronym: FARP

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2018
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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