NCT05027477Active, not recruiting
A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
Source: ClinicalTrials.gov · Last updated 17 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 18 Aug 2021
- Start date
- 1 Nov 2021
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Profound Medical Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT05027477
What you commit to
- Study type: Interventional
- Planned participants: 201
- From 1 Nov 2021 to the primary completion date, 31 Aug 2026
- 22 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Artificial urinary sphincter, penile implant, or intraprostatic implant
Other illness
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
Other
- 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
- Patients who are otherwise not deemed candidates for radical prostatectomy
- Inability or unwillingness to provide informed consent
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lawson Health Research Institute, London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Turku University Hospital/TYKS Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Johns Hopkins School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Arizona State Urological Institute Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Atlantic Urology Medical Group Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Comprehensive Urology Medical Group Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Urology Group of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| East Valley Urological Center Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Alarcon Urology Center Coordinator of this site? Confirm its status | Montebello | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Pasadena Urological Medical Group Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| The Urology Place Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Sarasota Memorial Health Care System Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Investigate Md Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Stanford Cancer Center Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.