CAPTAIN
A Comparison of the
TULSA Procedure vs. Radical Prostatectomy
in Participants with Localized Prostate Cancer

CAPTAIN
A Comparison of the
TULSA Procedure vs. Radical
Prostatectomy in Participants with
Localized Prostate Cancer

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.

TULSA-PRO

What is Radical Prostatectomy?

Radical Prostatectomy is a procedure performed using robotic technique or open surgery that involves the removal of your prostate and (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.

Radical Prostatectomy

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.

Download the checklist to see if you qualify

Download Brochure Here

Participant Journey Map

Screening

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.
Baseline

Once eligible, your study physician will do a clinical exam before your treatment and compare these measurements to a clinical exam after your treatment.
Randomization

You will be randomly assigned to either undergo the TULSA Procedure or a Radical Prostatectomy.
Treatment Visit

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.
Catheter Removal

Your study physician will decide the appropriate time and place for your catheter to be removed.
Follow-Up Appointments

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.

Participating Centers

Please click on the study center image and scroll to the bottom of the page for participating center contact information.

Treating Physicians

Visit Clinicaltrials.gov Contact Study Sponsor