Focal Prostate Ablation Versus Radical Prostatectomy

NCT03668652 | Completed

• 1 other identifier: 2017/703
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; HIFU and TULSA Focal Treatment; Radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Treatment failure.

  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 Outcomes (9)

• Focal ablation failure.

  Within 36 months from the treatment date.

• Total re-ablation rate

  Within 36 months from the treatment date.

• Diagnostic failure.

  Within 36 months from the treatment date.

• Cancer specific and all-cause mortality.

  Within 36 months from the treatment date.

• Difference in metastasis-free and overall survival.

  Within 36 months years from the treatment date.

Study Arms (2)

Focal prostate cancer treatment by HIFU

EXPERIMENTAL

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)

Radical Prostatectomy

ACTIVE COMPARATOR

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

Interventions

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

Focal prostate cancer treatment by HIFU

Radical prostatectomy PROCEDURE

Prostatectomy arm: Robot assisted or open retropubic prostatectomy

Radical Prostatectomy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Department of Cancer surgery, Oslo University Hospital, Radiumhospitalet

Oslo, 0514, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Eduard Baco, MD, PhD, Prof. assoc.

  Department of Cancer Surgery, Oslo University Hospital, Radiumhospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Focal treatment of prostate cancer using HIFU compared to Radical prostatectomy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: September 12, 2018
• Study Start: September 30, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)