Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Vanquish System


Participation Criteria
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Eligibility Criteria
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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 10-16 cores. <15mm diameter of qualifying 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. Exclusion Criteria: Patients with >GGG3 cores anywhere in the prostate MRI evidence of extracapsular extension of cancer (MRI read as definite, frank or gross ECE) All PI-RADS 5 lesions All MRI Central Imaging confirmed by PI-RADS 4 lesions negative on biopsy 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. Treated within the past 5 years 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 Treated within the past 5 years for a lower and/or 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, Multicenter, Single-Arm Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vanquish System Treatment<br> | Device: Vanquish System<br>* Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2. | 36 months | 
| Primary Safety Endpoint | The proportion of subjects free from new or worsening urinary incontinence based on pad use at 12 months will be statistically compared to a performance goal. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key Secondary Endpoint | The proportion of subjects free from impotence. | 36 months |