The Urology Group | Cincinnati, OH
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About
The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.
Enrollment
Sex
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Volunteers
Inclusion criteria
≥50 years of age; with life expectancy of ≥10 years
20-80 cc prostate size determined by MRI Central Imaging
≤15 ng/ml PSA
Cancer stage less than or equal to T2c
Within 12 months prior to signing consent have had a multiparametric MRI. Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal). This must include a standard sector biopsy obtaining a minimum of 10 cores.
Subject is willing and able to adhere to specific protocol visits and required testing throughout study
Is geographically stable and near the site or able and willing to travel back to site for follow-up visits involving diagnostic tests or treatment
Able and willing to provide written consent to participate in the study.
Subject is willing and able to be treated within 180 days after signing consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
400 participants in 1 patient group
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Central trial contact
Rachael Krzmarzick; Gabrielle Robinson
Data sourced from clinicaltrials.gov
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