What is CAPTAIN?
This study will determine whether the TULSA procedure is as effective and safer compared to radical prostatectomy.
What is the TULSA Procedure?
The Transurethral Ultrasound Ablation (TULSA) Procedure uses directional thermal ultrasound to ablate (destroy) diseased prostate tissue. It has been demonstrated to be safe and effective at ablating prostate tissue in men with localized, intermediate-risk prostate cancer. The TULSA-PRO® is FDA cleared for use in the United States, Canada and Europe.
What is Radical Prostatectomy?
Radical Prostatectomy is a procedure performed using robotic technique or open surgery that involves the removal of your prostate and seminal vesicles (and sometimes nearby lymph nodes). For men with localized, intermediate-risk prostate cancer, RP is recommended to be a standard-of-care treatment and has been proven in large randomized controlled trials to reduce the long-term risk of dying from prostate cancer.
PARTICIPATING IN CAPTAIN
If you are between 40 and 80 years of age with intermediate-risk prostate cancer, your study physician will review the eligibility criteria with you to see if you can participate in the CAPTAIN trial. You will be assigned to either the Radical Prostatectomy group or the TULSA Procedure group if you qualify.
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Participant Journey Map
Various tests, such as Magnetic Resonance Imaging (MRI), Biopsy, Prostate-Specific Antigen (PSA) test, CT scan (if necessary) and nuclear imaging (if necessary), will be conducted to determine whether you are eligible to participate in the study.
Once eligible, your study physician will do a clinical exam before your treatment and compare these measurements to a clinical exam after your treatment.
You will be randomly assigned to either undergo the TULSA Procedure or a Radical Prostatectomy.
You will undergo the treatment of your assigned group and will be discharged from the hospital accordingly. Regardless of which treatment you receive, you will leave the hospital with a catheter inserted.
Your study physician will decide the appropriate time and place for your catheter to be removed.
For every follow-up visit, you will need to answer questions about your quality-of-life, do a PSA test, tell your study physician about any side-effects you are experiencing and if you have undergone any other treatments for your prostate cancer.
Please click on the study center image and scroll to the bottom of the page for participating center contact information.