The purpose of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation Device (“Vanquish”) in subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer
VAPOR 2
Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
Prostate cancer
All genders
50-89
Recruiting now
Overview
Principal Investigator: Liyan Zhuang, MD
Contact Us
Stephanie Gomez
Study details
Inclusion Criteria
- 1. ≥50 years of age; with life expectancy of ≥10 years
- 2. 20-80cc prostate size measured by MRI
- 3. ≤15 ng/ml PSA
Exclusion Criteria
- 1. MRI evidence of extracapsular extension of cancer (MRI read as “definite,” “frank,” or
“gross” ECE) as determined by MRI Central Imaging - 2. Contraindications to MRI
- 3. Subjects with an installed pacemaker or other potentially electrically conductive
implants (e.g. ICD, drug infusion pump, neurostimulator and bladder stimulators)
implanted within 200mm (8 inches) of the Vanquish procedure Field Generator.
Implants that are within 200 mm (8 inches) and can be turned off for the duration of the
study procedure are acceptable.
Study Requirements
Participants will be followed-up for 7-days, 30-days, 90-days, 6-months, 12-months, 18-months, 24-months, 30-months, 36- months, 42-months, 48-months, 54-months, and 60-months. Subjects receiving an additional and/or repeat treatment will have 7-day, 30-day and 12- month visits after the repeat and/or additional treatments added to their follow-up schedule