Prostate Cancer Clinical Trial

Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

400

Study ID:

NCT05683691

Recruitment Status:

Recruiting

Sponsor:

Francis Medical Inc.

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There are 29 Locations for this study

See Locations Near You

Mayo Clinic- Phoenix
Phoenix Arizona, 85054, United States More Info
Emily Stricklin
Contact
[email protected]
Daniel Frendl, MD
Principal Investigator
Arizona Urology Specialists
Tucson Arizona, 85704, United States More Info
Erica Roman
Contact
[email protected]
Kalpesh Patel, MD
Principal Investigator
Memorial Care
Laguna Hills California, 92653, United States More Info
Tuyet Collucci
Contact
[email protected]
Daniel Su, MD
Principal Investigator
University of Southern California
Los Angeles California, 90089, United States More Info
Ileana Aldana
Contact
[email protected]
Andre Abreu, MD
Principal Investigator
Baptist Health
Boynton Beach Florida, 23243, United States More Info
Jacqueline Landrian
Contact
[email protected]
Raymond Leveillee, MD
Principal Investigator
Kasraeian Urology
Jacksonville Florida, 32216, United States More Info
Miguel Alcantara
Contact
[email protected]
Ali Kasraeian, MD
Principal Investigator
Associated Urological Specialists
Chicago Ridge Illinois, 60615, United States More Info
Devang Shah
Contact
[email protected]
Aaron Berger, MD
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States More Info
Megan Mendez
Contact
[email protected]
Abhinav Sidana, MD
Principal Investigator
Wichita Urology
Wichita Kansas, 67226, United States More Info
Tyler Gentry
Contact
[email protected]
Philippe Nabbout, MD
Principal Investigator
Chesapeake Urology
Baltimore Maryland, 21204, United States More Info
Katie Wright
Contact
[email protected]
Richard Levin, MD
Principal Investigator
Johns Hopkins
Baltimore Maryland, 21287, United States More Info
Michael Ayenew
Contact
[email protected]
Arvin George, MD
Principal Investigator
Tufts
Boston Massachusetts, 02111, United States More Info
Stephanie Gomez
Contact
[email protected]
Liyan Zhuang, MD
Principal Investigator
Michigan Institute of Urology
Troy Michigan, 48084, United States More Info
Channing Sesoko
Contact
[email protected]
Kenneth Kernen, MD
Principal Investigator
University of Minnesota
Minneapolis Minnesota, 55454, United States More Info
Maressa Twedt
Contact
[email protected]
Christopher Warlick, MD
Principal Investigator
Mayo Clinic- Rochester
Rochester Minnesota, 55905, United States More Info
Wendy Sundt
Contact
[email protected]
Lance Mynderse, MD
Principal Investigator
Minnesota Urology
Woodbury Minnesota, 55125, United States More Info
Diane Kachel
Contact
[email protected]
Aaron Milbank, MD
Principal Investigator
NYU Langone Health
New York New York, 10016, United States More Info
Dayna Leis
Contact
[email protected]
Samir Taneja, MD
Principal Investigator
Northwell Health- Lenox Hill Hospital
New York New York, 11222, United States More Info
Cynthia Knauer
Contact
[email protected]
Ivan Grunberger, MD
Principal Investigator
University of Rochester
Rochester New York, 14620, United States More Info
Austin Jackson
Contact
[email protected]
Thomas Frye, DO
Principal Investigator
WMC Health- Good Samaritan Hospital
Suffern New York, 10901, United States More Info
Danielle Hansen
Contact
[email protected]
Mitchell Fraiman, MD
Principal Investigator
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Shawna Pochan
Contact
[email protected]
Thomas Polascik, MD
Principal Investigator
The Urology Group
Cincinnati Ohio, 45212, United States More Info
William Corbett
Contact
[email protected]
Marc Pliskin, DO
Principal Investigator
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Kathy Markopoulos
Contact
[email protected]
Laurence Belkoff, DO
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Lindsey Rabon
Contact
[email protected]
Neal Shore, MD
Principal Investigator
Urology Austin
Austin Texas, 78745, United States More Info
Jennifer Penshorn
Contact
[email protected]
Brian Mazzarella, MD
Principal Investigator
Houston Methodist Hospital and Research Institute
Houston Texas, 77030, United States More Info
Vivian MacDonnell
Contact
[email protected]
Brian Miles, MD
Principal Investigator
The Urology Place
San Antonio Texas, 78240, United States More Info
Victoria Sarwan
Contact
[email protected]
Naveen Kella, MD
Principal Investigator
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States More Info
Sabrina Delfenthal
Contact
[email protected]
Robert Given, MD
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Modar Aldakkak
Contact
[email protected]
Arjun Sivaraman, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

400

Study ID:

NCT05683691

Recruitment Status:

Recruiting

Sponsor:


Francis Medical Inc.

How clear is this clinincal trial information?

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