Water Vapor Ablation for Prostate Cancer
(VAPOR 2 Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
Yes, if you are taking medications that affect the prostate or PSA, like 5 alpha reductase inhibitors, androgen blockers, LHRH agonists or antagonists, or testosterone supplements, you will need to stop them. There are specific washout periods: 6 months for 5 alpha reductase inhibitors, 12 months for LHRH agonists or antagonists, and 3 months for testosterone supplements. Also, you must be able to stop taking antiplatelet medications or other blood thinners.
Do I need to stop taking my current medications for the trial?
If you are taking medications that affect hormones related to the prostate or PSA, such as 5 alpha reductase inhibitors, androgen blockers, LHRH agonists or antagonists, or testosterone supplements, you may need to stop them for a specific period before joining the trial. Other medications, like blood thinners, may also need to be stopped. Please consult with the trial team for specific guidance.
What data supports the idea that Water Vapor Ablation for Prostate Cancer is an effective treatment?
The available research does not provide specific data on the effectiveness of Water Vapor Ablation for Prostate Cancer. Instead, it discusses other treatments like high-intensity focused ultrasound (HIFU) and cryoablation, which are also used for prostate cancer. These treatments aim to control cancer while reducing the treatment burden and avoiding the psychological impact of constant monitoring. Without specific data on Water Vapor Ablation, it's unclear how it compares to these other methods.12345
What data supports the effectiveness of the treatment Vanquish System, Vanquish Water Vapor Ablation Device, Vanquish System for prostate cancer?
The research suggests that minimally invasive ablative therapies, like high-intensity focused ultrasound (HIFU), are effective for localized prostate cancer, offering a balance between active surveillance and more aggressive treatments. This implies that similar ablative treatments, such as water vapor ablation, may also be effective in managing prostate cancer while potentially reducing treatment burden.12345
What safety data exists for water vapor ablation for prostate cancer?
The safety data for water vapor ablation, specifically transurethral water vapor therapy (TWVT), indicates that it has fewer severe or life-threatening adverse events compared to other treatments like aquablation and prostatic urethral lift (PUL). In a national registry, TWVT had 24 severe or life-threatening adverse events out of 157 reported, which is significantly lower than aquablation and PUL. Additionally, TWVT had a very low rate of blood transfusions (1%) and the most common device malfunction was an unresolvable error message. Overall, TWVT appears to have a favorable safety profile compared to other BPH treatments.678910
Is water vapor ablation therapy generally safe for treating prostate conditions?
Transurethral water vapor therapy (TWVT) for benign prostatic hyperplasia (BPH) has shown a lower rate of severe or life-threatening adverse events compared to other treatments, with only 15% of reported cases being severe. The most common issue was an unresolvable error message, and only 1% of cases required a blood transfusion, indicating it is relatively safe.678910
Is the Vanquish System treatment a promising option for prostate cancer?
Yes, the Vanquish System treatment is promising for prostate cancer because it aims to reduce the treatment burden while maintaining cancer control. It offers a less invasive option compared to traditional methods like surgery or radiation, potentially improving the quality of life for patients.14111213
How does the Vanquish System treatment for prostate cancer differ from other treatments?
The Vanquish System uses water vapor ablation, which is a novel approach compared to traditional methods like surgery or radiation. This treatment aims to reduce the treatment burden while maintaining cancer control, offering a less invasive option that avoids the psychological impact of constant monitoring.14111213
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Vanquish Water Vapor Ablation Device for prostate cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Vanquish System
Vanquish System is already approved in United States for the following indications:
- Localized intermediate-risk prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Francis Medical Inc.
Lead Sponsor