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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanquish System Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanquish System | Device | Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2. | 36 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Endpoint | The proportion of subjects free from impotence. | 36 months |
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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 cores.
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.
Subject is willing and able to be treated within 180 days after signing consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic- Phoenix | Phoenix | Arizona | 85054 | United States | ||
| Memorial Care |
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Prospective, Multicenter, Single-Arm Study
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| Laguna Hills |
| California |
| 92653 |
| United States |
| University of Southern California | Los Angeles | California | 90089 | United States |
| Kasraeian Urology | Jacksonville | Florida | 32216 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Wichita Urology | Wichita | Kansas | 67226 | United States |
| Chesapeake Urology | Baltimore | Maryland | 21204 | United States |
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Corewell Health / William Beaumont University Hospital | Royal Oak | Michigan | 48073 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Mayo Clinic- Rochester | Rochester | Minnesota | 55905 | United States |
| Minnesota Urology | Woodbury | Minnesota | 55125 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Northwell Health- Lenox Hill Hospital | New York | New York | 11222 | United States |
| University of Rochester | Rochester | New York | 14620 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| The Urology Group | Cincinnati | Ohio | 45212 | United States |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Austin | Austin | Texas | 78745 | United States |
| Houston Methodist Hospital and Research Institute | Houston | Texas | 77030 | United States |
| The Urology Place | San Antonio | Texas | 78240 | United States |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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