Focal Prostate Ablation Versus Radical Prostatectomy (FARP)

University of Oslo (UIO)

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical); Procedure: Radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03668652

2017/703

Details and patient eligibility

About

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

Full 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.

Enrollment: 213 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

Focal prostate cancer treatment by HIFU

Experimental group

Description:

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.

Treatment:

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

Radical Prostatectomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Radical prostatectomy