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

Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Adenocarcinoma
• Intervention / Treatment: Device: Radical Prostatectomy; Device: TULSA Procedure

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.

• Study Type: Interventional
• Enrollment (Estimated): 201
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gina Clarke; Phone Number: 416-689-8156; Email: gclarke@profoundmedical.com
• Study Contact Backup: Name: Arthi Rajamohan; Phone Number: 442 647-476-1350; Email: arajamohan@profoundmedical.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 2R5
      • Recruiting
      • Lawson Health Research Institute, London Health Sciences Centre
      • Principal Investigator: Brant Inman, MD
      • Contact: Wendy Shoff; Phone Number: 57350 519-685-8500; Email: Wendy.Shoff@lhsc.on.ca
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Research Institute
      • Contact: Marlene Kebabdjian; Phone Number: 2890 416-480-6100; Email: Marlene.Kebabdjian@sunnybrook.ca
      • Principal Investigator: Laurence Klotz, MD
• Finland
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20520
      • Recruiting
      • Turku University Hospital/TYKS
      • Principal Investigator: Mikael Anttinen, MD PhD
      • Contact: Kaisa Reunanen; Phone Number: 358 02 313 3647; Email: Kaisa.Reunanen@tyks.fi
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Recruiting
      • East Valley Urological Center
      • Contact: Marchelle Mehan; Phone Number: 480-219-1010
      • Principal Investigator: Rahul Mehan, MD
  • California
    • Downey, California, United States, 90241
      • Recruiting
      • Genesis Healthcare
      • Contact: Joseph Greco; Phone Number: 818-990-5020; Email: joseph.greco@uniohp.com
      • Principal Investigator: Pooya Banapour, MD
    • Long Beach, California, United States, 90806
      • Recruiting
      • Atlantic Urology Medical Group
      • Sub-Investigator: Bart Wachs, MD
      • Contact: Francisco Capilla; Phone Number: 213-926-1844; Email: francisco@folioclinicalresearch.com
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Comprehensive Urology Medical Group
      • Principal Investigator: Kiarash Michel, MD
      • Contact: Shahzada Khurram; Phone Number: 424-337-1411; Email: SKhurram@Comprehensive-Urology.com
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Urology Group of Southern California
      • Contact: Carlos Lopez; Phone Number: 213-212-4313
      • Contact: Email: carlos@folioclinicalresearch.com
      • Sub-Investigator: John Kowalczyk, DO
    • Montebello, California, United States, 90640
      • Recruiting
      • Alarcon Urology Center
      • Contact: Yvette Zuniga; Phone Number: 626-284-9278; Email: yvette@folioclinicalresearch.com
      • Sub-Investigator: Juan Antonio Alarcon, MD
    • Pasadena, California, United States, 91101
      • Recruiting
      • Pasadena Urological Medical Group
      • Contact: Francisco Capilla; Phone Number: 213-926-1844; Email: francisco@folioclinicalresearch.com
      • Sub-Investigator: Shahin Chandrasoma, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Cancer Center
      • Contact: Julia Gallagher-Teske; Phone Number: 650-723-5543; Email: jgteske@stanford.edu
      • Contact: Kristine Talavera; Phone Number: 650-725-0525; Email: kriscima@stanford.edu
      • Principal Investigator: Geoffrey Sonn, MD
    • West Hills, California, United States, 91307
      • Recruiting
      • San Fernando Valley Urological Associates Medical Group, Inc.
      • Principal Investigator: Ali-Reza Sharif-Afshar, MD
      • Contact: Ali-Reza Sharif-Afshar
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale Cancer Center
      • Contact: Kristin DeFrancesco; Phone Number: 203-785-3852; Email: kristin.defrancesco@yale.edu
      • Principal Investigator: Sandeep Arora, MD
      • Sub-Investigator: Preston Sprenkle, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: John Applegate; Phone Number: 317-278-1641; Email: jwappleg@iu.edu
      • Principal Investigator: Michael Koch, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins School of Medicine
      • Principal Investigator: Christian Pavlovich, MD
      • Contact: Sandy Moore-Cooper; Phone Number: 410-955-0009; Email: mooresa@jhmi.edu
      • Contact: Carolyn Chapman; Phone Number: 443-287-7841; Email: cchapma7@jhmi.edu
  • Texas
    • Dallas, Texas, United States, 75390-9020
      • Recruiting
      • The University of Texas Southwestern Medical Center
      • Contact: Phillip McDuffie; Phone Number: 214-645-8787; Email: Phillip.mcduffie@utsouthwestern.edu
      • Principal Investigator: Xiaosong Meng, MD
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • The Urology Place
      • Principal Investigator: Naveen Kella, MD
      • Contact: Naveen Kella, MD; Phone Number: 210-617-3670; Email: nkella@theupi.com
      • Contact: Victoria Sarwan; Phone Number: 210-617-3670; Email: victoria@theupi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radical Prostatectomy; Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.	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.
Experimental: TULSA Procedure; Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.	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.; Other Names: TULSA-PRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy endpoint - proportion of patients free from treatment failure	Compare the proportion of patients experiencing treatment failure, between the 2 arms. Treatment failure is defined as delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy), or metastatic disease, or prostate cancer-specific death.	36 months post-treatment
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency	Compare preservation of urinary continence and erectile potency, between the 2 arms. Urinary continence is defined as 'pad-free' (0 pads/day) (per EPIC question 5) and erectile potency is defined as erection firmness sufficient for penetration (per IIEF question 2).	12 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological failure endpoint	Compare the proportion of patients who have clinically significant disease (defined as ISUP Grade Group 2 or higher) between the two arms.	At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA
mpMRI endpoint (for Tulsa arm only)	Characterize the effect of the TULSA Procedure ablation on diagnostic multi-parametric MRI, determined using PI-RADS V2 score, compared to baseline.	At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA
Salvage-free survival endpoint	Compare the proportion of patients who are salvage free, between the two arms. Salvage-free survival is defined as freedom from any salvage treatments after the assigned treatment, for both RP arm and TULSA arm. 1 repeat TULSA does not count as Salvage.	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
Metastases-free survival endpoint	Compare the proportion of patients who are free from metastatic disease between the 2 arms, based on imaging.	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
Prostate cancer-specific survival endpoint	Compare the proportion of patients who die of prostate cancer between the 2 arms.	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
Overall survival endpoint	Compare the proportion of patients who die of any cause, between the 2 arms.	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
Surgical complications endpoint	Compare the frequency and severity of all adverse events between the 2 arms, evaluated by attribution and reported in accordance with Clavien-Dindo classification.	At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years
Penile rehabilitation endpoint	Compare the proportion of patients who undergo penile rehabilitation between the 2 arms (penile rehab includes implant insertion, medication/injection, traction or pump device).	At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years
Penile length endpoint	Compare the change in penile length from baseline to after treatment, between the 2 arms, as measured by the study doctor.	At 1 month and 12 months post-treatment
Blood loss endpoint	Compare the volume of blood lost between the two arms during treatment.	During the procedure and immediately after the procedure
Transfusion volume endpoint	Compare the volume of transfused blood between the two arms during treatment.	During the procedure and immediately after the procedure
IIEF-15 Endpoint	Compare International Index of Erectile Function (IIEF-15) scores (for domains of sexual function) between the two arms at follow up, referenced to baseline. Low scores indicate a worse outcome.	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
IPSS Endpoint	Compare International Prostate Symptom Score (IPSS) scores (for urinary function), between the two arms at follow up, referenced to baseline. Minimum score=0, Maximum score=35. Higher scores indicate a worse outcome.	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
NRS Endpoint	Compare Numerical Rating Scale (NRS) ratings (which measures pain intensity), between the two arms at follow up, referenced to baseline. 0 indicates no pain and 10 indicates worst possible pain.	At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
EQ-5D-5L Endpoint	Compare the EQ-5D-5L scores (which measures quality of life), between the two arms at follow up, referenced to baseline. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (Mobility, self-care, usual activities, pain/discomfort and anxiety expression), where level 1 indicates no problem and level 5 indicates extreme problem.	At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.
Biochemical failure endpoint	Compare the proportion of patients with biochemical failure between the two arms. Biochemical failure is defined as PSA≥ 0.2 ng/mL for the RP arm or PSA nadir plus 2 ng/mL for the TULSA arm (adapted from Phoenix criteria).	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
Inpatient hospital stay endpoint	Compare the length of inpatient stay between the two arms.	Immediately after the procedure
EPIC Endpoint	Compare (Expanded Prostate Cancer Index Composite) EPIC scores (for domains of urinary, sexual, bowel, and hormonal function), scored from 0 (worst) to 100 (best) between the two arms at follow up, referenced to baseline.	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

Collaborators and Investigators

• Sponsor: Profound Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): December 9, 2024
• Study Completion (Estimated): December 9, 2034

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; TULSA; radical prostatectomy; minimally invasive; high intensity transurethral ultrasound ablation; MRI-guided; real-time temperature feedback control; Prostate ablation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: GCP-10296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes