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Procedure
TULSA Procedure vs. Radical Prostatectomy for Prostate Cancer (CAPTAIN Trial)
N/A
Recruiting
Research Sponsored by Profound Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male
Biopsy-confirmed, NCCN (favorable and unfavourable) intermediate-risk prostate acquired within last 12 months
Timeline
Screening 3 days
Treatment Varies
Follow Up 120 months
Awards & highlights
Summary
This trial compares a new treatment with traditional surgery in men with prostate cancer. The goal is to see if the new treatment can effectively treat cancer while preserving important functions better than surgery. Patients will be followed for several years to assess outcomes. The new treatment is minimally invasive and uses advanced technology to target prostate tissue.
Who is the study for?
Men aged 40-80 with intermediate-risk, localized prostate cancer (Stage ≤T2c, N0, M0) and a life expectancy of over 10 years. Participants must have had a recent biopsy confirming the condition and not undergone any previous treatments for it. Those with certain urinary or anal implants, history of fibrosis or stenosis challenging device insertion, inability to undergo MRI/general anesthesia, or severe bladder conditions cannot join.
What is being tested?
This study is comparing two procedures in men with prostate cancer: radical prostatectomy (surgery to remove the entire prostate gland) versus TULSA procedure (a less invasive technique using ultrasound). Patients will be randomly assigned to one of these treatments and followed up for 10 years to assess effectiveness and safety.
What are the potential side effects?
Radical prostatectomy can cause urinary incontinence, erectile dysfunction, pain and bleeding post-surgery. The TULSA procedure may result in similar side effects but is expected to be safer; specific side effects will be studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am male.
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My prostate cancer is intermediate-risk, confirmed by a biopsy in the last year.
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My cancer is in an early stage and has not spread to lymph nodes or other parts of my body.
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My prostate cancer is classified as ISUP Grade Group 2 or 3.
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I have not received any treatment for my condition.
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My treatment area near the urethra is less than 3 cm, confirmed by a recent MRI.
Timeline
Screening ~ 3 days3 visits
Treatment ~ Varies
Follow Up ~ 120 months5 visits
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~120 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy endpoint - proportion of patients free from treatment failure
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
Secondary study objectives
Biochemical failure endpoint
Blood loss endpoint
EPIC Endpoint
+15 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TULSA ProcedureExperimental Treatment1 Intervention
Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.
Group II: Radical ProstatectomyActive Control1 Intervention
Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The TULSA procedure uses high-intensity ultrasound waves to ablate prostate tissue, effectively destroying cancerous cells through thermal energy. This method is minimally invasive and aims to preserve surrounding healthy tissue.
Other common treatments include radical prostatectomy, which surgically removes the prostate gland, and androgen deprivation therapy (ADT), which lowers male hormone levels to slow cancer growth. Understanding these mechanisms helps patients make informed decisions about their treatment options, considering factors like effectiveness, safety, and potential side effects.
Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.[Local treatment of prostate cancer using thermal-ablative energy].
Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.[Local treatment of prostate cancer using thermal-ablative energy].
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Profound Medical Inc.Lead Sponsor
3 Previous Clinical Trials
1,180 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,180 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Radical Prostatectomy
- Group 2: TULSA Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Prostate Cancer Patient Testimony for trial: Trial Name: NCT05027477 — N/A
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