Water Vapor Ablation for Grade Group 3 Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorFrancis Medical Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Participant has been diagnosed with Grade Group 3 (GG3) intermediate risk prostate cancer.
≤20 ng/ml PSA.
PSA density ≤0.15
≥50 years of age; with life expectancy of ≥10 years.
Disqualifiers
Participants with ≥GG4 cores anywhere in the prostate.
Participants with GG2 or GG3 cores outside the region of interest.
Contraindications per the Vanquish Instructions For Use.
Any previous treatment for prostate cancer or any prior surgery, intervention, or minimally invasive therapy (MIST) for the prostate or bladder neck, including but not limited to Vanquish therapy, TUIP, TURP, Aquablation, Green Light, Rezūm, Prostatic Urethral Lift, iTind, Prostatic Arterial Embolization, or microwave therapy.
Trial design
Treatments tested in this trial
- Water Vapor Ablation
Treatment groups
120 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov