Level 1 evidence comparing emerging modalities for prostate ablation with standard of care therapies is lacking. TULSA may provide a safer treatment option than radical prostatectomy for men with prostate cancer if proven in a head-to-head comparison. The CAPTAIN RCT will provide game-changing evidence that may define a less invasive treatment option for men with intermediate-risk prostate cancer
The TULSA Procedure is a new, minimally-invasive technique that uses real-time MRI-guided technology to guide the delivery of high-energy ultrasound to precisely, and in a customized fashion specific to you, heat and kill the prostate cancer tissue while protecting important surrounding body parts that are important for preserving urinary and sexual function. The TULSA Procedure is approved for use by the United States Food and Drug Administration (FDA), Health Canada and in Europe to ablate prostate tissue using ultrasound energ
What is Radical Prostatectomy
There are two types of radical prostatectomy: minimally invasive and open surgical procedures. The typical standard of care for is radical prostatectomy. Although radical prostatectomy is good at controlling the cancer, it may leave men with significant long-term effects in urinary and sexual function, thus reducing your quality of life.
Eligibility & Randomization
Once you have passed screening and are eligible for the study, we will use a computer to assign you to one of the study groups (either TULSA Study Procedure or radical prostatectomy). This process is called “randomization.” It means that your study doctor will not choose, and you cannot choose which study group you are in. You will be put into a group by chance. You will have a 2 in 3 chance of getting the TULSA Study Procedure versus a 1 in 3 chance of getting the radical prostatectomy.