Water Vapor Ablation for Grade Group 3 Prostate Cancer (NCT07652164) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Water Vapor Ablation for Grade Group 3 Prostate Cancer
120 participantsStarted 2026-07-31
Plain-language summary
The goal of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation System ("Vanquish") in participants with Grade Group 3 (GG3) intermediate-risk prostate cancer.
Participants will undergo therapy with the Vanquish System and complete follow up visits at 7 days, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. mpMRI results must show localized disease meaning a single MRI region of suspicion (PI-RADS ≥3 with lesion volume ≤1.5 cc).
. Maximum lesion diameter in any MRI dimension must be ≤11.9 mm.
. Central Pathology confirmation showing a minimum of 2 cores in aggregate of pattern 4 disease (GG3) in the targeted lesion identified by Central Imaging
. GG1 cores from anywhere in the prostate are acceptable
. Less than 50% of systematic biopsy cores are positive for GGG 1 or 2 disease. For the \<50% calculation, all systematic positive cores located in the sector(s) containing the target, or in sectors immediately adjacent to the qualifying target, are counted as "one core."
. PSMA-PET results show no suspicion of metastasis as determined by site read
. Per Radiology Central Imaging, PSMA-PET scan prostate results are concordant with mpMRI results
. If PSMA indicates a hotspot separate from the lesion or planned treatment area, a targeted repeat biopsy is required to rule out ≥ GG2
Exclusion criteria
. 5 alpha reductase inhibitors, if on for \< 6 months (6-month washout required if participant is able and willing to stop medication)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ablative Efficacy 6-Months Post Ablation
Timeframe: 6 months post procedure.
2
Rate of Serious Adverse Events Through 6-Months
Timeframe: From the start of the Vanquish procedure through 6-months post procedure.