A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

NCT05027477 | Active Not Recruiting FDA Device

• 1 other identifier: GCP-10296
• Study Type: interventional
• Target: 201
• Locations: 3 countries
• Sites: 22

Brief Summary

Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate ablation; high intensity transurethral ultrasound ablation; MRI-guided; minimally invasive; real-time temperature feedback control; prostate cancer; TULSA; radical prostatectomy

Outcome Measures

Primary Outcomes (2)

• Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency

  Compare preservation of urinary continence and erectile potency, between the 2 arms. Urinary continence is defined as 'pad-free' (0 pads/day) (per EPIC question 5) and erectile potency is defined as erection firmness sufficient for penetration (per IIEF question 2).

  12 months post-treatment

• Efficacy endpoint - proportion of patients free from treatment failure

  Compare the proportion of patients experiencing treatment failure, between the 2 arms. Treatment failure is defined as delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy), or metastatic disease, or prostate cancer-specific death.

  36 months post-treatment

Secondary Outcomes (18)

• Biochemical failure endpoint

  At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years

• Histological failure endpoint

  At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA

• mpMRI endpoint (for Tulsa arm only)

  At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA

• Salvage-free survival endpoint

  At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years

• Metastases-free survival endpoint

  At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years

Study Arms (2)

Radical Prostatectomy

ACTIVE COMPARATOR

Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.

Device: Radical Prostatectomy

TULSA Procedure

EXPERIMENTAL

Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.

Device: TULSA Procedure

Interventions

Radical Prostatectomy DEVICE

If you are in this group, you will get the standard of care treatment used to treat this type of cancer: radical prostatectomy. You will undergo this procedure as per standard clinical practice. A radical prostatectomy is a surgical procedure that removes the prostate gland. This is done by making a surgical incision and removing the prostate gland.

Radical Prostatectomy

TULSA Procedure DEVICE

If you are in this group, you will get the TULSA Procedure. The TULSA Procedure is a minimally invasive procedure that uses directional ultrasound to produce very high temperature to ablate (destroy) targeted prostate tissue. The procedure is performed in a MRI suite (the physician can see the prostate at all times throughout the procedure) and uses the TULSA-PRO system to ablate prostate tissue. The procedure combines real-time MRI with robotically-driven directional thermal ultrasound to deliver predictable, physician-prescribed ablation of the prostate. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like in traditional surgery.

Also known as: TULSA-PRO

TULSA Procedure

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age 40 to 80 years, with \>10 years life expectancy
• NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
• Stage ≤cT2c, N0, M0
• ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
• PSA ≤20ng/mL within last 3 months
• Treatment-naïve
• Planned ablation volume is \< 3 cm axial radius from urethra on mpMRI acquired within last 6 months

You may not qualify if:

• Inability to undergo MRI or general anesthesia
• Suspected tumor is \> 30 mm from the prostatic urethra
• Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor
• Unresolved urinary tract infection or prostatitis
• History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
• Artificial urinary sphincter, penile implant, or intraprostatic implant
• Patients who are otherwise not deemed candidates for radical prostatectomy
• Inability or unwillingness to provide informed consent
• History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices

Sponsors & Collaborators

• Profound Medical Inc.: lead

Study Sites (22)

Arizona State Urological Institute

Chandler, Arizona, 85224, United States

Location

East Valley Urological Center

Mesa, Arizona, 85206, United States

Location

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Atlantic Urology Medical Group

Long Beach, California, 90806, United States

Location

Urology Group of Southern California

Los Angeles, California, 90017, United States

Location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Comprehensive Urology Medical Group

Los Angeles, California, 90048, United States

Location

Alarcon Urology Center

Montebello, California, 90640, United States

Location

Pasadena Urological Medical Group

Pasadena, California, 91101, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9020, United States

Location

The Urology Place

San Antonio, Texas, 78240, United States

Location

Lawson Health Research Institute, London Health Sciences Centre

London, Ontario, N6C 2R5, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

Turku University Hospital/TYKS

Turku, Southwest Finland, 20520, Finland

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 30, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2036
• Last Updated: August 17, 2025

Record last verified: 2025-01

Locations

CA (2); US (19); FI (1)