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Procedure

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
No Placebo-Only Group

Summary

This trial is testing a device called Vanquish that uses steam to treat prostate cancer. It targets men with a specific type of intermediate-risk prostate cancer. The steam heats up and kills the cancer cells in the prostate.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint
Primary Safety Endpoint
Secondary study objectives
Key Secondary Endpoint

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vanquish System TreatmentExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often involve mechanisms that target and destroy cancerous tissues while minimizing damage to surrounding healthy tissues. Ablative therapies, such as the Vanquish Water Vapor Ablation Device, use thermal energy to ablate or destroy prostate tissue. This method is designed to be precise, reducing the risk of collateral damage and preserving prostate function. Radiation therapies, including Intensity-Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT), use high-energy particles to target and kill cancer cells, with advanced imaging techniques ensuring accuracy. Surgical options, like prostatectomy, physically remove the prostate gland or affected tissues. These mechanisms are crucial for patients as they offer targeted treatment options that aim to effectively manage cancer while minimizing side effects and preserving quality of life.
Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.

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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

Vanquish System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05683691 — N/A
Prostate Cancer Research Study Groups: Vanquish System Treatment
Prostate Cancer Clinical Trial 2023: Vanquish System Highlights & Side Effects. Trial Name: NCT05683691 — N/A
Vanquish System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683691 — N/A
~252 spots leftby Apr 2027