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

Study Identifier:
4760-001
CT.gov Identifier:
NCT05683691
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruitment Complete

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    (N/A)
    Sex
    N/A
    Age
    50+ years
    Study Drug
  • Drug: EXPERIMENTAL: Vanquish System Treatment
    • Read More
  • Drug: Drug: Vanquish System
  • Drug: Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • 1. ≥50 years of age; with life expectancy of ≥10 years
    • 2. 20-80 cc prostate size determined by MRI Central Imaging
    • 3. ≤15 ng/ml PSA
    • 4. Cancer stage less than or equal to T2c
    • 5. 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
    • 6. Subject is willing and able to adhere to specific protocol visits and required testing throughout study
    • 7. 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
    • 8. Able and willing to provide written consent to participate in the study.
    • 9. Subject is willing and able to be treated within 180 days after signing consent.
    Exclusion criteria
    • 1. Patients with >GGG3 cores anywhere in the prostate
    • 2. MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE)
    • 3. All MRI Central Imaging confirmed PI-RADS 5 lesions
    • 4. All MRI Central Imaging confirmed additional PI-RADS 4 lesions.
    • 5. Contraindications to MRI
    • 6. 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.
    • 7. Any prior surgery, intervention, or minimally invasive therapy, (MIST) for the prostate cancer or bladder neck.
    • 8. Treated within the past 5 years for genital cancer
    • 9. Presence of any urethral or prostatic condition that precludes water vapor ablation per Instructions for Use
    • 10. 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)
    • 11. 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.
    • 12. Active or clinically chronic prostatitis or granulomatous prostatitis
    • 13. Treated within the past 5 years for a lower and/or upper urinary tract malignancy.
    • 14. Any previous treatment for prostate cancer.
    • 15. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS
    • 16. Unable to stop taking antiplatelet medications or other blood thinning agents
    • 17. Known allergy to nickel
    • 18. Allergic to medication required by the study such as MRI contrast or anesthesia
    • 19. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
    • 20. 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
    • 21. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
    • 22. Subject is considered vulnerable such as incarcerated or cognitively impaired.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate