NCT05683691Active, not recruitingNot Applicable
Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
Francis Medical Inc.26 sites in 1 country400 target enrollmentStarted: May 16, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 26
- Primary Endpoint
- Primary Safety Endpoint
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
- •<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.
- •Subject is willing and able to be treated within 180 days after signing consent.
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 MRI Central Imaging confirmed PI-RADS 5 lesions
- •All MRI Central Imaging confirmed additional PI-RADS 4 lesions.
- •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, 6-month washout), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12-month washout), or Testosterone supplementation (3-month washout)
- •Active urinary tract infection. Subjects with an active infection who can be treated and re-tested with a negative result within the screening window are acceptable.
- •Active or clinically chronic prostatitis or granulomatous prostatitis
- •Treated within the past 5 years for a lower and/or upper urinary tract malignancy.
- •Any previous treatment for prostate cancer.
- •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.
Arms & Interventions
Vanquish System Treatment
Experimental
Intervention: Vanquish System (Device)
Outcomes
Primary Outcomes
Primary Safety Endpoint
Time Frame: 12 months
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.
Primary Effectiveness Endpoint
Time Frame: 36 months
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
Secondary Outcomes
- Key Secondary Endpoint(36 months)
Investigators
Study Sites (26)
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