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

Conditions

Prostate Cancer, Prostate Adenocarcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona State Urological Institute, Chandler, Arizona, United States, 85224

Mesa

East Valley Urological Center, Mesa, Arizona, United States, 85206

Scottsdale

Investigate MD, Scottsdale, Arizona, United States, 85255

Downey

Genesis Healthcare, Downey, California, United States, 90241

Long Beach

Atlantic Urology Medical Group, Long Beach, California, United States, 90806

Los Angeles

Urology Group of Southern California, Los Angeles, California, United States, 90017

Los Angeles

Comprehensive Urology Medical Group, Los Angeles, California, United States, 90048

Montebello

Alarcon Urology Center, Montebello, California, United States, 90640

Pasadena

Pasadena Urological Medical Group, Pasadena, California, United States, 91101

Stanford

Stanford Cancer Center, Stanford, California, United States, 94305

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Profound Medical Inc.,

Study Record Dates

2034-12-09