Prostate Cancer Clinical Trial
Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer
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.
≥50 years of age; with life expectancy of ≥10 years
20-80 cc prostate size measured by MRI
≤15 ng/ml PSA
Cancer stage less than or equal to T2c
Within 6 months of 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 12-16 cores.
≤15mm diameter of lesion as measure by greatest diameter
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.
MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE)
Contraindications to MRI
Subjects with an installed pacemaker or other potentially electrically conductive implants implanted within 200mm (8 inches) of the procedure area. Implants that are within 200mm (8 inches) and can be turned off for the duration of the study procedure are acceptable.
Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
Previous treatment for genital cancer
Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use
Currently taking medications that have hormonal effects on the prostate or PSA, such as: 5 alpha reductase inhibitors (if on for <6 months), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12 month wash-out), or Testosterone supplementation
Active urinary tract infection
Active or clinically chronic prostatitis or granulomatous prostatitis
Active lower and upper urinary tract malignancy (excluding prostate cancer meeting the inclusion criteria)
Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS
Unable to stop taking antiplatelet medications or other blood thinning agents
Known allergy to nickel
Allergic to medication required by the study such as MRI contrast or anesthesia
Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires
Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
Subject is considered vulnerable such as incarcerated or cognitively impaired.
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There is 1 Location for this study
San Antonio Texas, 78240, United States More Info
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