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TULSA Procedure vs. Radical Prostatectomy for Prostate Cancer (CAPTAIN Trial)
CAPTAIN Trial Summary
This trial will compare a new, less invasive prostate cancer treatment to the standard surgery. Researchers will track patients for 10 years to see if the new treatment is just as effective and less risky.
CAPTAIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCAPTAIN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CAPTAIN Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Media Library
- My cancer is in an early stage and has not spread.My prostate cancer is classified as ISUP Grade Group 2 or 3.I have a history of tightness or blockages in my anal, rectal, or urethral areas that make it hard to insert medical devices.My prostate cancer is intermediate-risk, confirmed by a biopsy in the last year.My prostate cancer is intermediate-risk and confirmed by a biopsy in the last year.My cancer is in an early stage and has not spread to lymph nodes or other parts of my body.My prostate cancer is classified as ISUP Grade Group 2 or 3.I am male.You have an artificial urinary sphincter, penile implant, or an implant in your prostate.My treatment area near the urethra is less than 3 cm, confirmed by a recent MRI.I am male.I have not received any treatment for my condition.I am not considered a candidate for major prostate surgery.I am between 45 and 80 years old and expected to live more than 10 years.My treatment area near the urethra is less than 3 cm, confirmed by a recent MRI.I am between 40 and 80 years old and expected to live more than 10 years.I cannot have an MRI or be put under general anesthesia.I have had issues with my bladder or urinary tract, like infections or stones.
- Group 1: Radical Prostatectomy
- Group 2: TULSA Procedure
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 120 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the full scope of healthcare institutions participating in this experiment?
"At present, 10 clinical trial sites are actively participating in this study. These locations include Baltimore, Tarzana and Dallas as well as other cities across the country. Thus, prospective participants should consider selecting a facility near them to reduce their travel needs."
Could I possibly become part of this research endeavor?
"To qualify for this research project, individuals should possess a prostate cancer diagnosis and fall within the age range of 40 to 80 years old. A total of 201 eligible patients are being accepted into the study."
Is participation in this experiment still being accepted?
"The pertinent information stored on clinicaltrials.gov informs us that this trial is still open to participants, having been posted initially in November 2021 and updated lastly late the following year."
What is the current participant enrollment for this research endeavor?
"Affirmative. Per the information on clinicaltrials.gov, this experiment is actively seeking candidates and was initially posted on November 1st 2021 before being updated most recently on November 23rd 2022. The trial requires 201 individuals from 10 distinct locations to participate."
Is it possible for individuals over the age of 45 to participate in this experiment?
"This medical trial mandates that participants are between 40 and 80 years of age. If you do not meet this criteria, there are 76 studies for minors and 1336 trials available to seniors."
What benefits are researchers hoping to observe through this medical experiment?
"The primary result of this medical experiment, assessed over 12 months following treatment, will be the proportion of patients free from failure. Secondary objectives include comparing biochemical failure rates between two arms with PSA≥ 2 ng/mL for the RP arm or PSA nadir plus 2 ng/mL for the TULSA arm (Phoenix criteria), measuring International Prostate Symptom Score (IPSS) scores against baseline values ranging from 0 to 35 where higher numbers indicate a worsening condition, and determining differences in penile length at baseline and post-treatment as measured by study doctors."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Urology Group of Southern California: < 48 hours
- Comprehensive Urology Medical Group: < 48 hours
Typically responds via
Average response time
- < 2 Days
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