Focal Prostate Ablation Versus Radical Prostatectomy (FARP)

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: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical); Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Klara Sørbø, nurse; Phone Number: +47 23 03 31 88; Email: anklso@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0514
    • Recruiting
    • Department of Urology Aker, Oslo University Hospital
    • Contact: Eduard Baco, MD, PhD; Phone Number: +47 22 89 40 00; Email: Eduard.Baco@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• PSA ≤ 20 ng/ml
• Initial diagnosis of localized prostate cancer (stage ≤ T2b)
• Biopsy proven unilateral prostate cancer Gleason score 3+3 and not eligible to active surveillance program [cancer invades over a length of at least 5 mm and MRI demonstrates cancer suspicious lesion score ESUR ≥ 4/5 localized in line with the biopsy AND/OR Gleason score 3+4 (without length criteria of positive biopsies or tumor volume on MRI)
• Patients may have biopsy verified clinically insignificant prostate cancer on the contra-lateral prostate lobe (Gleason score 3+3, maximal cancer core length < 5 mm, MRI score ESUR ≤ 3)

Exclusion Criteria:

• Clinical stage T3
• Metastatic lymph node on MRI or CT
• Patients already treated for Pca (hormone therapy, EBRT)
• Patients with contra-indications to MRI
• Patients with inflammatory bowel disease or 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 > 30 mm from the rectum will be treated with TULSA applied by TULSA-PRO.	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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure.	Treatment failure in HIFU focal ablation arm is classified as the need for secondary whole gland treatment as radical prostatectomy or EBRT. Treatment failure in radical prostatectomy arm is classified as PSA > 0.2 or positive surgical margins and need for EBRT.	At 36 months from the treatment date.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare urinary continence between focal ablation and radical prostatectomy.	Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire for the evaluation of continence will be used. Variation in urinary continence according to the number of pads used/day due to continence problems compared to baseline. Categories are 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.
To compare erectile function between focal ablation and radical prostatectomy.	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.
To compare quality of life between focal ablation and radical prostatectomy.	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.
Focal ablation failure.	Focal ablation failure is classified as presence of clinically significant cancer on control MRI-3D TRUS image fusion guided biopsy in the treated prostate zone. At least 2 targeted biopsy cores will be localized in the treatment zone. Prostate biopsy will be performed at 12 and 36 months from the treatment date.	Within 36 months from the treatment date.
To compare short, medium and long term adverse events related to treatments.	All adverse events will be registered prospectively.	Within 36 months from the treatment date
Diagnostic failure.	Diagnostic failure is classified as diagnosis of clinically significant cancer localized outside of treatment zone in treated lobe and in any region of non- treated prostate lobe. MRI and systematic radom prostate biopsy form each prostate sextant will be performed and location of each biopsy trajectory will be registered using Trinity (Koelis) device. Prostate biopsy will be performed at 12 and 36 months from the treatment date.	Within 36 months from the treatment date.
Cancer progression including development of metastases.	Whole body MRI or PET CT will be performed if suspicion on metastases.	Within 36 months years from the treatment date.
Cancer specific and all-cause mortality.	Cause of the mortality will be evaluated and registered.	Within 36 months from the treatment date.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Eduard Baco, MD, PhD, Department of Urology Aker, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2017
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2024

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): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Prostate Cancer; Radical prostatectomy; HIFU Focal Treatment
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• 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