Prostate Cancer Clinical Trial
A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Male
Age 40 to 80 years, with >10 years life expectancy
Biopsy-confirmed, NCCN (favorable and unfavourable) intermediate-risk prostate acquired within last 12 months
Stage ≤cT2c, N0, M0
ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
PSA ≤20ng/mL within last 3 months
Treatment-naïve
Planned ablation volume is < 3 cm axial radius from urethra on mpMRI acquired within last 6 months
Exclusion Criteria:
Inability to undergo MRI or general anesthesia
Suspected tumor is > 30 mm from the prostatic urethra
Prostate calcifications is > 3 mm in maximum extent obstructing ablation of tumor
Unresolved urinary tract infection or prostatitis
History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
Artificial urinary sphincter, penile implant, or intraprostatic implant
Patients who are otherwise not deemed candidates for radical prostatectomy
Inability or unwillingness to provide informed consent
History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
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There are 9 Locations for this study
Downey California, 90241, United States More Info
Principal Investigator
Los Angeles California, 90048, United States More Info
Principal Investigator
West Hills California, 91307, United States More Info
Principal Investigator
New Haven Connecticut, 06511, United States More Info
Principal Investigator
Sub-Investigator
Baltimore Maryland, 21287, United States More Info
Principal Investigator
Dallas Texas, 75390, United States More Info
Principal Investigator
San Antonio Texas, 78240, United States More Info
Principal Investigator
London Ontario, N6C 2, Canada More Info
Principal Investigator
Toronto Ontario, M4N 3, Canada More Info
Principal Investigator
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