ACTIVE_NOT_RECRUITING

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

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Conditions

Prostate CancerProstate AdenocarcinomaProstate ablationhigh intensity transurethral ultrasound ablationMRI-guidedminimally invasivereal-time temperature feedback controlTULSAradical prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-01
Study Completion:2036-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05027477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male
  2. * Age 40 to 80 years, with \>10 years life expectancy
  3. * NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
  4. * Stage ≤cT2c, N0, M0
  5. * ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
  6. * PSA ≤20ng/mL within last 3 months
  7. * Treatment-naïve
  8. * Planned ablation volume is \< 3 cm axial radius from urethra on mpMRI acquired within last 6 months
  1. * Inability to undergo MRI or general anesthesia
  2. * Suspected tumor is \> 30 mm from the prostatic urethra
  3. * Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor
  4. * Unresolved urinary tract infection or prostatitis
  5. * History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
  6. * Artificial urinary sphincter, penile implant, or intraprostatic implant
  7. * Patients who are otherwise not deemed candidates for radical prostatectomy
  8. * Inability or unwillingness to provide informed consent
  9. * History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices

Contacts and Locations

Study Locations (Sites)

Arizona State Urological Institute
Chandler, Arizona, 85224
United States
East Valley Urological Center
Mesa, Arizona, 85206
United States
Investigate MD
Scottsdale, Arizona, 85255
United States
Atlantic Urology Medical Group
Long Beach, California, 90806
United States
Urology Group of Southern California
Los Angeles, California, 90017
United States
University of California, Los Angeles
Los Angeles, California, 90024
United States
Comprehensive Urology Medical Group
Los Angeles, California, 90048
United States
Alarcon Urology Center
Montebello, California, 90640
United States
Pasadena Urological Medical Group
Pasadena, California, 91101
United States
Stanford Cancer Center
Stanford, California, 94305
United States
Yale Cancer Center
New Haven, Connecticut, 06511
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Cleveland Clinic
Cleveland, Ohio, 44106
United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9020
United States
The Urology Place
San Antonio, Texas, 78240
United States

Collaborators and Investigators

Sponsor: Profound Medical Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01
Study Completion Date2036-08-31

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2036-08-31

Terms related to this study

Keywords Provided by Researchers

  • Prostate ablation
  • high intensity transurethral ultrasound ablation
  • MRI-guided
  • minimally invasive
  • real-time temperature feedback control
  • prostate cancer
  • TULSA
  • radical prostatectomy

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Prostate Adenocarcinoma