NCT05027477

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (estimated)
• Sponsor: Profound Medical Inc. · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The typical standard of care for patients with localized, intermediate risk prostate cancer is radical prostatectomy, which involves the surgical removal of the prostate. Although radical prostatectomy is effective in terms of controlling the cancer, it may leave men with significant long-term effects in urinary, sexual function like erectile dysfunction and/or incontinence (loss of bladder control), thus reducing quality of life. Preservation of continence (ability to control your bladder) and potency (ability to achieve erection and/or ejaculation) may be significant concerns for men. Targeted ablation of localized prostate cancer using MRI-guided technology is becoming a favorable option for many men who wish to have their cancer treated but do not wish to compromise their urinary and sexual functions. 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. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like traditional surgery or minimally invasive surgery. The purpose of this research study is to: * Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy). * Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer. About 201 subjects will participate in this study with 67 randomly assigned to the radical prostatectomy group and 134 randomly assigned to the TULSA procedure group. Patients will have a 1 in 3 chance of being assigned to the radical prostatectomy group and a 2 in 3 chance of being assigned to the TULSA group. Following treatment, patients will be followed up for 10 years.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Radical Prostatectomy	If you are in this group, you will get the standard of care treatment used to treat this type of cancer: radical prostatectomy. You will undergo this procedure as per standard clinical practice. A radical prostatectomy is a surgical procedure that removes the prostate gland. This is done by making a surgical incision and removing the prostate gland.
DEVICE	TULSA Procedure	If you are in this group, you will get the TULSA Procedure. The TULSA Procedure is a minimally invasive procedure that uses directional ultrasound to produce very high temperature to ablate (destroy) targeted prostate tissue. The procedure is performed in a MRI suite (the physician can see the prostate at all times throughout the procedure) and uses the TULSA-PRO system to ablate prostate tissue. The procedure combines real-time MRI with robotically-driven directional thermal ultrasound to deliver predictable, physician-prescribed ablation of the prostate. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like in traditional surgery.

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-08-31
• Completion: 2036-08-31
• First posted: 2021-08-30
• Last updated: 2025-08-17

Locations

22 sites across 3 countries: United States, Canada, Finland

Regulatory

• FDA-regulated device study