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Trial Title: Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

NCT ID: NCT05683691

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Acetaminophen, aspirin, caffeine drug combination

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prospective, Multicenter, Single-Arm Study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Vanquish System
Description: Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
Arm group label: Vanquish System Treatment

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.

Criteria for eligibility:
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 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.

Gender: Male

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic- Phoenix

Address:
City: Phoenix
Zip: 85054
Country: United States

Status: Recruiting

Contact:
Last name: Emily Stricklin
Email: stricklin.emily@mayo.edu

Contact backup:
Last name: Daniel Frendl, MD

Facility:
Name: Memorial Care

Address:
City: Laguna Hills
Zip: 92653
Country: United States

Status: Recruiting

Contact:
Last name: Tuyet Collucci
Email: tcollucci@memorialcare.org

Contact backup:
Last name: Daniel Su, MD

Facility:
Name: University of Southern California

Address:
City: Los Angeles
Zip: 90089
Country: United States

Status: Recruiting

Contact:
Last name: Ileana Aldana
Email: ileana.aldana@med.usc.edu

Contact backup:
Last name: Andre Abreu, MD

Facility:
Name: Golden State Urology

Address:
City: Sacramento
Zip: 95823
Country: United States

Status: Not yet recruiting

Contact:
Last name: Sehaj Sethi

Phone: 9162458888
Email: ssethi@goldenstateurology.com

Contact backup:
Last name: Prithipal Sethi, MD

Facility:
Name: University of California, San Francisco

Address:
City: San Francisco
Zip: 94143
Country: United States

Status: Not yet recruiting

Contact:
Last name: Imelda Tenggara

Phone: 415-353-7348
Email: Imelda.Tenggara@ucsf.edu

Contact backup:
Last name: Katsuto Shinohara, MD

Facility:
Name: Baptist Health

Address:
City: Boynton Beach
Zip: 232435
Country: United States

Status: Recruiting

Contact:
Last name: Jigar Modi
Email: jigar.modi@baptisthealth.net

Contact backup:
Last name: Raymond Leveillee, MD

Facility:
Name: Kasraeian Urology

Address:
City: Jacksonville
Zip: 32216
Country: United States

Status: Recruiting

Contact:
Last name: Miguel Alcantara
Email: miguel@kasraeianurology.com

Contact backup:
Last name: Ali Kasraeian, MD

Facility:
Name: Associated Urological Specialists

Address:
City: Chicago Ridge
Zip: 60615
Country: United States

Status: Recruiting

Contact:
Last name: Devang Shah
Email: d.shah@auspecialists.com

Contact backup:
Last name: Aaron Berger, MD

Facility:
Name: University of Chicago

Address:
City: Chicago
Zip: 60637
Country: United States

Status: Recruiting

Contact:
Last name: Megan Mendez
Email: megan.mendez@bsd.uchicago.edu

Contact backup:
Last name: Abhinav Sidana, MD

Facility:
Name: Wichita Urology

Address:
City: Wichita
Zip: 67226
Country: United States

Status: Recruiting

Contact:
Last name: Tyler Gentry
Email: tgentry@wichitaurology.com

Contact backup:
Last name: Philippe Nabbout, MD

Facility:
Name: WK Advanced Urology Specialists

Address:
City: Shreveport
Zip: 71111
Country: United States

Status: Recruiting

Contact:
Last name: Tracey Robinson
Email: Trobinson9@wkhs.com

Contact backup:
Last name: Gerard Henry, MD

Facility:
Name: Chesapeake Urology

Address:
City: Baltimore
Zip: 21204
Country: United States

Status: Recruiting

Contact:
Last name: Michaelina Bowers
Email: michaelina.bowers@chesuro.com

Contact backup:
Last name: Richard Levin, MD

Facility:
Name: Johns Hopkins

Address:
City: Baltimore
Zip: 21287
Country: United States

Status: Recruiting

Contact:
Last name: Michael Ayenew
Email: mayenew1@jhmi.edu

Contact backup:
Last name: Arvin George, MD

Facility:
Name: Corewell Health / William Beaumont University Hospital

Address:
City: Royal Oak
Zip: 48073
Country: United States

Status: Not yet recruiting

Contact:
Last name: Jennifer Giordano
Email: jennifer.giordano@corewellhealth.org

Contact backup:
Last name: Bradley Rosenberg, MD

Facility:
Name: Michigan Institute of Urology

Address:
City: Troy
Zip: 48084
Country: United States

Status: Recruiting

Contact:
Last name: Danielle Osterhout
Email: OsterhoutD@michiganurology.com

Contact backup:
Last name: Kenneth Kernen, MD

Facility:
Name: University of Minnesota

Address:
City: Minneapolis
Zip: 55454
Country: United States

Status: Recruiting

Contact:
Last name: Maressa Twedt
Email: twedt050@umn.edu

Contact backup:
Last name: Christopher Warlick, MD

Facility:
Name: Mayo Clinic- Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Kerry Peterson
Email: Peterson.Kerry@mayo.edu

Contact backup:
Last name: Lance Mynderse, MD

Facility:
Name: Minnesota Urology

Address:
City: Woodbury
Zip: 55125
Country: United States

Status: Recruiting

Contact:
Last name: Mitch Brenner
Email: mbrenner@mnurology.com

Contact backup:
Last name: Aaron Milbank, MD

Facility:
Name: NYU Langone Health

Address:
City: New York
Zip: 10016
Country: United States

Status: Recruiting

Contact:
Last name: Dayna Leis
Email: Dayna.Leis@nyulangone.org

Contact backup:
Last name: Samir Taneja, MD

Facility:
Name: Northwell Health- Lenox Hill Hospital

Address:
City: New York
Zip: 11222
Country: United States

Status: Recruiting

Contact:
Last name: Cynthia Knauer
Email: cknauer1@northwell.edu

Contact backup:
Last name: Ivan Grunberger, MD

Facility:
Name: University of Rochester

Address:
City: Rochester
Zip: 14620
Country: United States

Status: Recruiting

Contact:
Last name: Marcus D'Alfonso
Email: Marcus_Dalfonso@URMC.Rochester.edu

Contact backup:
Last name: Thomas Frye, DO

Facility:
Name: WMC Health- Good Samaritan Hospital

Address:
City: Suffern
Zip: 10901
Country: United States

Status: Recruiting

Contact:
Last name: Danielle Hansen
Email: Danielle.Hansen@wmchealth.org

Contact backup:
Last name: Mitchell Fraiman, MD

Facility:
Name: Duke Cancer Institute

Address:
City: Durham
Zip: 27710
Country: United States

Status: Recruiting

Contact:
Last name: Shawna Pochan
Email: shawna.pochan@duke.edu

Contact backup:
Last name: Thomas Polascik, MD

Facility:
Name: The Urology Group

Address:
City: Cincinnati
Zip: 45212
Country: United States

Status: Recruiting

Contact:
Last name: William Corbett
Email: wcorbett@urologygroup.com

Contact backup:
Last name: Marc Pliskin, DO

Facility:
Name: MidLantic Urology

Address:
City: Bala-Cynwyd
Zip: 19004
Country: United States

Status: Recruiting

Contact:
Last name: Kelly Liberatore
Email: kliberatore@midlanticurology.com

Contact backup:
Last name: Laurence Belkoff, DO

Facility:
Name: Carolina Urologic Research Center

Address:
City: Myrtle Beach
Zip: 29572
Country: United States

Status: Recruiting

Contact:
Last name: Lindsey Rabon
Email: lrabon@curcmb.com

Contact backup:
Last name: Neal Shore, MD

Facility:
Name: Conrad Pearson Clinic

Address:
City: Memphis
Zip: 38138
Country: United States

Status: Not yet recruiting

Contact:
Last name: Russel Grigsby
Email: rsgrigsby@conradpearson.com

Contact backup:
Last name: Robert Hollabaugh, MD

Facility:
Name: Urology Austin

Address:
City: Austin
Zip: 78745
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer Penshorn
Email: jennifer.penshorn@urologyaustin.com

Contact backup:
Last name: Brian Mazzarella, MD

Facility:
Name: Urology Clinics of North Texas

Address:
City: Dallas
Zip: 75231
Country: United States

Status: Not yet recruiting

Contact:
Last name: Stephanie Berger
Email: sberger@urologyclinics.com

Contact backup:
Last name: Gregory Thoreson, MD

Facility:
Name: Houston Methodist Hospital and Research Institute

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Vivian MacDonnell
Email: vmmacdonnell@houstonmethodist.org

Contact backup:
Last name: Brian Miles, MD

Facility:
Name: The Urology Place

Address:
City: San Antonio
Zip: 78240
Country: United States

Status: Recruiting

Contact:
Last name: Raji Thiruppathiraj
Email: raji@theupi.com

Contact backup:
Last name: Naveen Kella, MD

Facility:
Name: Urology of Virginia, PLLC

Address:
City: Virginia Beach
Zip: 23462
Country: United States

Status: Recruiting

Contact:
Last name: Sabrina Delfenthal
Email: sabrinaa.delfenthal@urologyofva.net

Contact backup:
Last name: Robert Given, MD

Facility:
Name: Medical College of Wisconsin

Address:
City: Milwaukee
Zip: 53226
Country: United States

Status: Recruiting

Contact:
Last name: Modar Aldakkak
Email: moaldakkak@mcw.edu

Contact backup:
Last name: Arjun Sivaraman, MD

Start date: May 16, 2023

Completion date: April 2029

Lead sponsor:
Agency: Francis Medical Inc.
Agency class: Industry

Source: Francis Medical Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05683691

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