400 Participants Needed

Water Vapor Ablation for Prostate Cancer

(VAPOR 2 Trial)

Recruiting at 35 trial locations
GR
AS
RK
Overseen ByRachael Krzmarzick
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

I can travel to the clinic for follow-ups and treatments.
<15mm diameter of qualifying lesion as measured by greatest diameter
Within 12 months prior to signing consent have had a multiparametric MRI
See 7 more

Exclusion 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.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Vanquish Water Vapor Ablation Device for prostate cancer

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

  • Vanquish System
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Vanquish System TreatmentExperimental Treatment1 Intervention

Vanquish System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Vanquish System for:
  • Localized intermediate-risk prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Francis Medical Inc.

Lead Sponsor

Trials
2
Recruited
430+

Findings from Research

Focal therapy for prostate cancer, using various energy modalities like cryotherapy, high-intensity focused ultrasound (HIFU), and photodynamic therapy (PDT), shows promise in effectively ablating tumors while minimizing treatment burden and psychological stress associated with active surveillance.
These therapies have demonstrated short-term effectiveness with low morbidity, although the complexity and cost of the required technology may limit their accessibility; ongoing research aims to refine these techniques for optimal patient outcomes.
Target ablation--image-guided therapy in prostate cancer.Marien, A., Gill, I., Ukimura, O., et al.[2022]
Systemic therapies for prostate cancer are expected to improve significantly, which will greatly enhance treatment options for high-risk and locally advanced cases.
Advancements in radiotherapy and local treatment methods like cryoablation will provide more effective local control options for prostate cancer, indicating a promising future for treatment strategies.
NCCN Practice Guidelines for Prostate Cancer.Bahnson, RR., Hanks, GE., Huben, RP., et al.[2005]
A total of 172 men with localized prostate cancer treated with HIFU (High-Intensity Focused Ultrasound) showed promising short-term results, with 92.4% achieving no evidence of disease after one treatment, indicated by a PSA level of less than 0.5 microg/ml.
The procedure was minimally invasive, with low rates of side effects: only 7% experienced mild urinary incontinence, and 70% maintained erectile function after 12 months, suggesting HIFU is a safe and effective option for managing localized prostate cancer.
High-intensity-focused ultrasound in the treatment of primary prostate cancer: the first UK series.Ahmed, HU., Zacharakis, E., Dudderidge, T., et al.[2021]

References

Target ablation--image-guided therapy in prostate cancer. [2022]
NCCN Practice Guidelines for Prostate Cancer. [2005]
High-intensity-focused ultrasound in the treatment of primary prostate cancer: the first UK series. [2021]
Quality of life and functional outcome after infravesical desobstruction and HIFU treatment for localized prostate cancer. [2018]
The primary treatment of prostate cancer with high-intensity focused ultrasound: A systematic review and meta-analysis. [2022]
Time Course of Incident Adverse Experiences Associated with Doxazosin, Finasteride and Combination Therapy in Men with Benign Prostatic Hyperplasia: The MTOPS Trial. [2022]
Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry. [2023]
Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. [2021]
Water Vapor Thermal Therapy in Men with Prostate Volume &#8805;80 cm3: A Systematic Review and Meta-Analysis. [2023]
Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15). [2019]
Vascular-targeted photodynamic therapy (padoporfin, WST09) for recurrent prostate cancer after failure of external beam radiotherapy: a study of escalating light doses. [2022]
[Management of ablative therapies in prostate cancer]. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Critical review of the efficacy and safety of cryotherapy of the prostate. [2022]