Comparing TULSA Procedure and Radical Prostatectomy for 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)
This study is testing whether a new, less invasive treatment called the TULSA procedure can effectively treat localized prostate cancer with fewer side effects compared to traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | Profound Medical Inc. Academic / other |
| Locations | 23 sites (Chandler, Arizona and 22 other locations) |
| Trial ID | NCT05027477 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves men with localized, intermediate risk prostate cancer who will be randomly assigned to receive either the TULSA procedure or radical prostatectomy. The TULSA procedure is a minimally invasive treatment that uses MRI-guided technology to deliver high-energy ultrasound to target and destroy cancerous tissue while preserving surrounding structures important for urinary and sexual function. Participants will be followed for 10 years to assess the effectiveness and safety of the TULSA procedure compared to the traditional surgical approach. The study aims to determine if TULSA can provide similar cancer control with fewer long-term side effects.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 80 with localized, intermediate risk prostate cancer who have not received prior treatment.
Not a fit: Patients with tumors located too far from the prostatic urethra or those with certain urinary or prostate conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer treatment option for prostate cancer that minimizes the risk of urinary and sexual dysfunction.
How similar studies have performed: While the TULSA procedure is a newer approach, similar minimally invasive techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Chandler, Arizona and 22 other locations
- Arizona State Urological Institute — Chandler, Arizona, United States (Recruiting)
- East Valley Urological Center — Mesa, Arizona, United States (Recruiting)
- Investigate MD — Scottsdale, Arizona, United States (Recruiting)
- Genesis Healthcare — Downey, California, United States (Withdrawn)
- Atlantic Urology Medical Group — Long Beach, California, United States (Recruiting)
- Urology Group of Southern California — Los Angeles, California, United States (Recruiting)
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- Comprehensive Urology Medical Group — Los Angeles, California, United States (Recruiting)
- Alarcon Urology Center — Montebello, California, United States (Recruiting)
- Pasadena Urological Medical Group — Pasadena, California, United States (Recruiting)
- Stanford Cancer Center — Stanford, California, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Sarasota Memorial Health Care System — Sarasota, Florida, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- The Urology Place — San Antonio, Texas, United States (Recruiting)
- Lawson Health Research Institute, London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Sunnybrook Research Institute — Toronto, Ontario, Canada (Recruiting)
- Turku University Hospital/TYKS — Turku, Varsinais-Suomi, Finland (Recruiting)
Study contacts
- Study coordinator: Gina Clarke
- Email: gclarke@profoundmedical.com
- Phone: 416-689-8156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.