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Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05683691
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : November 28, 2023
Sponsor:
Information provided by (Responsible Party):
Francis Medical Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Vanquish System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Multicenter, Single-Arm Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
Actual Study Start Date : May 16, 2023
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Vanquish

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vanquish System Treatment Device: Vanquish System
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: 36 months ]
    Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.

  2. 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.


Secondary Outcome Measures :
  1. Key Secondary Endpoint [ Time Frame: 36 months ]
    The proportion of subjects free from impotence.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 10-16 cores.
  6. <15mm diameter of qualifying lesion as measure by greatest diameter
  7. Subject is willing and able to adhere to specific protocol visits and required testing throughout study
  8. 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
  9. Able and willing to provide written consent to participate in the study.

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 PI-RADS 5 lesions
  4. All MRI Central Imaging confirmed by PI-RADS 4 lesions negative on biopsy
  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), Androgen blockers, Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (12 month wash-out), or Testosterone supplementation
  11. Active urinary tract infection
  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 (excluding prostate cancer meeting the inclusion criteria)
  14. Any rectal pathology, anomaly or previous treatment that could change properties of rectal wall or insertion and use of TRUS
  15. Unable to stop taking antiplatelet medications or other blood thinning agents
  16. Known allergy to nickel
  17. Allergic to medication required by the study such as MRI contrast or anesthesia
  18. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study
  19. 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
  20. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
  21. Subject is considered vulnerable such as incarcerated or cognitively impaired.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05683691


Contacts
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Contact: Gabrielle Robinson (763) 951-0370 grobinson@francismedical.com
Contact: Andrea Stone (763) 951-0370 astone@francismedical.com

Locations
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Sponsors and Collaborators
Francis Medical Inc.
More Information
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Responsible Party: Francis Medical Inc.
ClinicalTrials.gov Identifier: NCT05683691    
Other Study ID Numbers: 4760-001
First Posted: January 13, 2023    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
 Acetaminophen, aspirin, caffeine drug combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents