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

NAActive, not recruitingINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2036

Conditions
Prostate CancerProstate Adenocarcinoma
Interventions
DEVICE

Radical Prostatectomy

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.

DEVICE

TULSA Procedure

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.

Trial Locations (22)

20520

Turku University Hospital/TYKS, Turku

21287

Johns Hopkins School of Medicine, Baltimore

32224

Mayo Clinic Jacksonville, Jacksonville

34239

Sarasota Memorial Health Care System, Sarasota

44106

Cleveland Clinic, Cleveland

46202

Indiana University, Indianapolis

55905

Mayo Clinic, Rochester

78240

The Urology Place, San Antonio

85206

East Valley Urological Center, Mesa

85224

Arizona State Urological Institute, Chandler

85255

Investigate MD, Scottsdale

90017

Urology Group of Southern California, Los Angeles

90024

University of California, Los Angeles, Los Angeles

90048

Comprehensive Urology Medical Group, Los Angeles

90640

Alarcon Urology Center, Montebello

90806

Atlantic Urology Medical Group, Long Beach

91101

Pasadena Urological Medical Group, Pasadena

94305

Stanford Cancer Center, Stanford

06511

Yale Cancer Center, New Haven

75390-9020

The University of Texas Southwestern Medical Center, Dallas

N6C 2R5

Lawson Health Research Institute, London Health Sciences Centre, London

M4N 3M5

Sunnybrook Research Institute, Toronto

All Listed Sponsors
lead

Profound Medical Inc.

OTHER