A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

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.