Focal Prostate Ablation Versus Radical Prostatectomy

A Randomized Control Trial of Focal Prostate Ablation Versus Radical Prostatectomy

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

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.

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