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Water Vapor Ablation for Prostate Cancer (VAPOR 2 Trial)
N/A
Recruiting
Research Sponsored by Francis Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
VAPOR 2 Trial Summary
This trial will evaluate a new device to treat prostate cancer in men with intermediate-risk Gleason Grade Group 2.
Who is the study for?
Men over 50 with a life expectancy of at least 10 years, diagnosed with intermediate-risk prostate cancer (Gleason Grade Group 2), and have not had previous treatments for it. They must live near or be able to travel to the trial site for follow-ups, have a prostate size of 20-80 cc measured by MRI, PSA levels ≤15 ng/ml, and cancer stage ≤T2c. Participants need to have undergone specific diagnostic biopsies within the last six months.Check my eligibility
What is being tested?
The Vanquish Water Vapor Ablation Device is being tested for its safety and effectiveness in treating localized intermediate-risk prostate cancer. The device uses water vapor to ablate (destroy) cancerous tissue in the prostate.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include irritation or damage to surrounding tissues, urinary symptoms like difficulty urinating or increased frequency, pain or discomfort during recovery.
VAPOR 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint
Secondary outcome measures
Key Secondary Endpoint
VAPOR 2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Vanquish System TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Francis Medical Inc.Lead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Prostate Cancer
26 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has a Gleason score above 3.I have been treated for genital cancer in the last 5 years.My MRI shows my cancer has spread beyond its original location.My MRI showed suspicious areas, but the biopsy was negative.I do not have any urethral or prostatic conditions that prevent water vapor treatment.I have ongoing or chronic prostate inflammation.I have had surgery or a procedure for prostate cancer or at the bladder neck.I have been treated for bladder or urinary tract cancer, not including prostate cancer, in the last 5 years.I can travel to the clinic for follow-ups and treatments.I am 50 years or older with an expected lifespan of 10 more years.I have no rectal conditions or past treatments that could affect rectal exams.I've had a detailed prostate biopsy in the last 6 months.I cannot stop my blood thinning medication.I am currently on medication that affects my prostate or PSA levels.I currently have a urinary tract infection.My prostate size is between 20-80 cc according to an MRI.My cancer is at an early stage (T2c or less).
Research Study Groups:
This trial has the following groups:- Group 1: Vanquish System Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any capacity to join this investigation currently?
"Affirmative. Clinicaltrials.gov confirms that this research program, which was initially posted on March 1st 2023 and most recently updated on March 8th 2023 is actively looking for participants. 400 patients are needed from one medical centre."
Answered by AI
How numerous are the participants in this clinical experiment?
"Affirmative. Information available on clinicaltrials.gov shows that this medical trial is actively looking for participants to join, beginning with its initial posting date of March 1st 2023 and the most recent update being on March 8th 2023. 400 people are needed from single site in order to complete this study's recruitment process."
Answered by AI
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