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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vanquish System
Sponsored by
Francis Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic- Phoenix
  • Memorial Care
  • University of Southern CaliforniaRecruiting
  • Baptist Health
  • Kasraeian UrologyRecruiting
  • Associated Urological Specialists
  • University of Chicago
  • Wichita Urology
  • Chesapeake UrologyRecruiting
  • Johns Hopkins
  • Tufts
  • Michigan Institute of UrologyRecruiting
  • University of MinnesotaRecruiting
  • Mayo Clinic- RochesterRecruiting
  • Minnesota UrologyRecruiting
  • NYU Langone HealthRecruiting
  • Northwell Health- Lenox Hill HospitalRecruiting
  • University of RochesterRecruiting
  • WMC Health- Good Samaritan HospitalRecruiting
  • Duke Cancer InstituteRecruiting
  • The Urology GroupRecruiting
  • MidLantic UrologyRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Urology AustinRecruiting
  • Houston Methodist Hospital and Research Institute
  • The Urology PlaceRecruiting
  • Urology of Virginia, PLLCRecruiting
  • Medical College of Wisconsin
  • Advocate Aurora Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vanquish System Treatment

Arm Description

Outcomes

Primary Outcome Measures

Primary Effectiveness Endpoint
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
Primary Safety Endpoint
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

Key Secondary Endpoint
The proportion of subjects free from impotence.

Full Information

First Posted
January 5, 2023
Last Updated
October 6, 2023
Sponsor
Francis Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05683691
Brief Title
Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer
Acronym
VAPOR 2
Official Title
Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Francis Medical Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, Multicenter, Single-Arm Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vanquish System Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vanquish System
Intervention Description
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
Time Frame
36 months
Title
Primary Safety Endpoint
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Key Secondary Endpoint
Description
The proportion of subjects free from impotence.
Time Frame
36 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabrielle Robinson
Phone
(763) 951-0370
Email
grobinson@francismedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Stone
Phone
(763) 951-0370
Email
astone@francismedical.com
Facility Information:
Facility Name
Mayo Clinic- Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Frendl, MD
Facility Name
Memorial Care
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Su, MD
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ileana Aldana
Email
ileana.aldana@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Andre Abreu, MD
Facility Name
Baptist Health
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
232435
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Landrian
Email
JacquieL@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Raymond Leveillee, MD
Facility Name
Kasraeian Urology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Alcantara
Email
miguel@kasraeianurology.com
First Name & Middle Initial & Last Name & Degree
Ali Kasraeian, MD
Facility Name
Associated Urological Specialists
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60615
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Berger, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sindy Thomas
Email
jesinde.thomas@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Scott Eggener, MD
Facility Name
Wichita Urology
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Richardson, MD
Facility Name
Chesapeake Urology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Wright
Email
Katie.Wright@chesuro.com
First Name & Middle Initial & Last Name & Degree
Richard Levin, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arvin George, MD
Facility Name
Tufts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Gomez
Email
stephanie.gomez@tuftsmedicine.org
First Name & Middle Initial & Last Name & Degree
Liyan Zhuang, MD
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Channing Sesoko
Email
sesokoc@michiganurology.com
First Name & Middle Initial & Last Name & Degree
Kenneth Kernen, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maressa Twedt
Email
twedt050@umn.edu
First Name & Middle Initial & Last Name & Degree
Christopher Warlick, MD
Facility Name
Mayo Clinic- Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Carlson
Email
gebel.holly@mayo.edu
First Name & Middle Initial & Last Name & Degree
Lance Mynderse, MD
Facility Name
Minnesota Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Kachel
Email
DKachel@mnurology.com
First Name & Middle Initial & Last Name & Degree
Aaron Milbank, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dayna Leis
Email
Dayna.Leis@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Samir Taneja, MD
Facility Name
Northwell Health- Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Tricarico
Email
ptricarico1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Ivan Grunberger, MD
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Jackson
Email
Austin_Jackson@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Thomas Frye, DO
Facility Name
WMC Health- Good Samaritan Hospital
City
Suffern
State/Province
New York
ZIP/Postal Code
10901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Hansen
Email
Danielle.Hansen@wmchealth.org
First Name & Middle Initial & Last Name & Degree
Mitchell Fraiman, MD
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawna Pochan
Email
shawna.pochan@duke.edu
First Name & Middle Initial & Last Name & Degree
Thomas Polascik, MD
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Corbett
Email
wcorbett@urologygroup.com
First Name & Middle Initial & Last Name & Degree
Marc Pliskin, DO
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Markopoulos
Email
kmarkopoulos@midlanticurology.com
First Name & Middle Initial & Last Name & Degree
Laurence Belkoff, DO
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Rabon
Email
lrabon@curcmb.com
First Name & Middle Initial & Last Name & Degree
Neal Shore, MD
Facility Name
Urology Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Penshorn
Email
jennifer.penshorn@urologyaustin.com
First Name & Middle Initial & Last Name & Degree
Brian Mazzarella, MD
Facility Name
Houston Methodist Hospital and Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian MacDonnell
Email
vmmacdonnell@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Brian Miles, MD
Facility Name
The Urology Place
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Sarwan
Email
victoria@theupi.com
First Name & Middle Initial & Last Name & Degree
Naveen Kella, MD
Facility Name
Urology of Virginia, PLLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Delfenthal
Email
sabrinaa.delfenthal@urologyofva.net
First Name & Middle Initial & Last Name & Degree
Robert Given, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Modar Aldakkak
Email
moaldakkak@mcw.edu
First Name & Middle Initial & Last Name & Degree
Arjun Sivaraman, MD
Facility Name
Advocate Aurora Health
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Ehlers, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer

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