Clinical trial NCT05027477: A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
Official title: Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Prostate ablation
high intensity transurethral ultrasound ablation
MRI-guided
minimally invasive
real-time temperature feedback control
prostate cancer
TULSA
radical prostatectomy
Lead sponsor: Profound Medical Inc.
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 201
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male
* Age 40 to 80 years, with \>10 years life expectancy
* NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy 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 \> 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

Primary outcomes:
measure: Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
timeFrame: 12 months post-treatment
measure: Efficacy endpoint - proportion of patients free from treatment failure
timeFrame: 36 months post-treatment
Secondary outcomes:
measure: Biochemical failure endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: Histological failure endpoint
timeFrame: At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA
measure: mpMRI endpoint (for Tulsa arm only)
timeFrame: At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA
measure: Salvage-free survival endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: Metastases-free survival endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: Prostate cancer-specific survival endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: Overall survival endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: Surgical complications endpoint
timeFrame: At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years
measure: Penile rehabilitation endpoint
timeFrame: At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years
measure: Penile length endpoint
timeFrame: At 1 month and 12 months post-treatment
measure: Blood loss endpoint
timeFrame: During the procedure and immediately after the procedure
measure: Transfusion volume endpoint
timeFrame: During the procedure and immediately after the procedure
measure: Inpatient hospital stay endpoint
timeFrame: Immediately after the procedure
measure: IIEF-15 Endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: IPSS Endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: EPIC Endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years
measure: NRS Endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
measure: EQ-5D-5L Endpoint
timeFrame: At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona State Urological Institute
state: Arizona
city: Mesa
country: United States
facility: East Valley Urological Center
state: Arizona
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Downey
country: United States
facility: Genesis Healthcare
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Comprehensive Urology Medical Group
state: California
city: Montebello
country: United States
facility: Alarcon Urology Center
state: California
city: Pasadena
country: United States
facility: Pasadena Urological Medical Group
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: London
country: Canada
facility: Lawson Health Research Institute, London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Turku
country: Finland
facility: Turku University Hospital/TYKS
state: Varsinais-Suomi
Study officials:
References: