Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05683691|
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : November 28, 2023
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Vanquish System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, Multicenter, Single-Arm Study|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR|
|Actual Study Start Date :||May 16, 2023|
|Estimated Primary Completion Date :||April 2027|
|Estimated Study Completion Date :||April 2029|
|Experimental: Vanquish System Treatment||
Device: Vanquish System
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
- Primary Effectiveness Endpoint [ Time Frame: 36 months ]Freedom from systemic disease AND systemic therapy AND salvage therapy AND GGG≥2.
- Primary Safety Endpoint [ Time Frame: 12 months ]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.
- Key Secondary Endpoint [ Time Frame: 36 months ]The proportion of subjects free from impotence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05683691
|Contact: Gabrielle Robinson||(763) firstname.lastname@example.org|
|Contact: Andrea Stone||(763) email@example.com|