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
