Water Vapor Ablation for Prostate Cancer

(VAPOR 2 Trial)

Not currently recruiting at 35 trial locations

Overseen By Rachael Krzmarzick

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Francis Medical Inc.

Must not be taking: Hormonal prostate medications

Disqualifiers: GGG3 cores, MRI ECE, PI-RADS 5, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called the Vanquish System, which uses water vapor ablation to target prostate cancer. It focuses on men with intermediate-risk prostate cancer, specifically those with Gleason Grade Group 2 localized cancer. Eligible participants must have confirmed prostate cancer through specific imaging and biopsy tests within the last year and a prostate size between 20-80 cc. The study aims to offer an alternative treatment option that might be less invasive than traditional methods.

As an unphased trial, this study explores innovative treatment options that could potentially improve quality of life.

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 prior data suggests that the Vanquish Water Vapor Ablation Device is safe for treating prostate cancer?

Research has shown that the Vanquish Water Vapor Ablation Device is likely safe. In one study with 15 patients, 14 tolerated the treatment well, indicating general safety. This suggests the treatment may have few side effects.

The Vanquish System is a minimally invasive device, typically involving less risk than more invasive procedures. While researchers are conducting more studies to gather additional information, the initial results are encouraging for those considering joining a clinical trial for this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Vanquish System is unique because it uses water vapor ablation to target prostate cancer. Unlike traditional treatments like surgery or radiation, which can have significant side effects, this method leverages the power of steam to destroy cancer cells with minimal impact on surrounding tissues. Researchers are excited about this approach because it promises a less invasive option with potentially fewer complications and faster recovery times for patients.

What evidence suggests that the Vanquish System is effective for treating localized intermediate-risk prostate cancer?

Research has shown that the Vanquish Water Vapor Ablation Device, used in this trial, can safely and effectively treat prostate cancer. This device uses steam to target and kill cancer cells. Patients with intermediate-risk prostate cancer have experienced promising results with this treatment. It is minimally invasive, avoiding major surgery, which can result in shorter recovery times and fewer side effects. Early evidence suggests it could be a good alternative for managing this type of cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

≤15 ng/ml PSA

Exclusion Criteria

My MRI shows my cancer has spread beyond its original location.

All PI-RADS 5 lesions

Contraindications to MRI

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Vanquish System

Trial Overview 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.

How Is the Trial Designed?

Group I: Vanquish System Treatment Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Francis Medical Inc.

Lead Sponsor

Trials

2

Recruited

430+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NCCN Practice Guidelines for Prostate Cancer. Bahnson, RR., Hanks, GE., Huben, RP., et al.[2005]

Modern cryoablation for prostate cancer has become a safer and more effective treatment option, showing long-term efficacy comparable to other therapies in low-risk patients and potentially superior results in moderate to high-risk groups.

Advancements in the procedure have led to a significant reduction in early complications, such as fistula formation and incontinence, with rates as low as 0% to 1%, while also improving recovery of erectile function through the use of vacuum erection devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of the efficacy and safety of cryotherapy of the prostate. Vestal, JC.[2022]

In a study of 3,047 men with lower urinary tract symptoms due to benign prostatic hyperplasia, the first year of treatment with doxazosin, finasteride, or combination therapy showed significantly higher rates of adverse experiences, particularly sexual function issues and dizziness.

Men on combination therapy reported the highest incidence of adverse effects in the first year, with rates 3.4 to 10.6 times higher than after the first year, highlighting the importance of monitoring and discussing these potential side effects with patients during initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time Course of Incident Adverse Experiences Associated with Doxazosin, Finasteride and Combination Therapy in Men with Benign Prostatic Hyperplasia: The MTOPS Trial. Kaplan, SA., Lee, JY., Meehan, AG., et al.[2022]

High-intensity focused ultrasound (HIFU) shows promising oncological outcomes for localized prostate cancer, with a mean prostate-specific antigen (PSA) nadir of 0.4 to 1.95 ng/mL after whole-gland treatment and 1.9 to 2.7 ng/mL after partial-gland treatment, indicating effective cancer control.

Partial-gland HIFU appears to be safer than whole-gland HIFU, with lower rates of complications such as urinary incontinence (2% vs. 10%) and impotence (21% vs. 44%), while achieving similar oncological results, suggesting it may be a preferable option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The primary treatment of prostate cancer with high-intensity focused ultrasound: A systematic review and meta-analysis. He, Y., Tan, P., He, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity-focused ultrasound in the treatment of primary prostate cancer: the first UK series. Ahmed, HU., Zacharakis, E., Dudderidge, T., et al.[2021]

TOOKAD vascular-targeted photodynamic therapy (VTP) effectively created large avascular regions in the prostate of patients with recurrent localized prostate cancer, with a complete negative biopsy response observed in 61.5% of patients receiving high light doses (≥23 J/cm²).

The treatment demonstrated minimal side effects, with most being self-limited, although there were two cases of recto-urethral fistulae, indicating a generally safe profile for this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular-targeted photodynamic therapy (padoporfin, WST09) for recurrent prostate cancer after failure of external beam radiotherapy: a study of escalating light doses. Trachtenberg, J., Weersink, RA., Davidson, SR., et al.[2022]

Ablative therapies for prostate cancer require careful management and specific protocols during pre-, per-, and post-procedure phases to ensure optimal outcomes.

The decision to use ablative therapies involves a consensus among medical staff and the patient's agreement, taking into account individual patient characteristics and economic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of ablative therapies in prostate cancer]. Barret, E., Sanchez-Salas, R., Galiano, M., et al.[2018]

In a study of 131 patients with localized prostate cancer, HIFU treatment demonstrated a biochemical recurrence-free survival rate of 73.7% for low-risk, 84.4% for intermediate-risk, and 62.5% for high-risk patients after an average follow-up of 22.2 months, indicating effective oncological outcomes.

Quality of life post-HIFU was reported to be better than that of the general population, with a mean global health score of 69.4, suggesting that HIFU is a safe and valuable treatment alternative for patients who are not suitable for standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and functional outcome after infravesical desobstruction and HIFU treatment for localized prostate cancer. Hatiboglu, G., Popeneciu, IV., Deppert, M., et al.[2018]

Aquablation and prostatic urethral lift (PUL) procedures for treating benign prostatic hyperplasia (BPH) were associated with significantly higher rates of severe complications compared to transurethral water vapor therapy (TWVT), with 78% of aquablation cases reporting severe events.

Common device malfunctions included rectal perforation in aquablation and issues with PUL implants, highlighting the importance of understanding potential risks associated with these treatments for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry. Kaplan-Marans, E., Martinez, M., Wood, A., et al.[2023]

A review of 2567 reports on various BPH treatment devices showed that over 99% of patients experienced no complications from device malfunctions, indicating a high level of safety across the modalities studied.

The use of morcellators during HoLEP was associated with the highest rate of serious complications, suggesting that urologists should be cautious and choose devices they are most familiar with to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. Patel, NH., Uppaluri, N., Iorga, M., et al.[2021]

Rezum therapy significantly improves lower urinary tract symptoms in men with large prostates (at least 80 cm³), with notable reductions in the International Prostate Symptom Score (IPSS) and improvements in urinary flow rate (Qmax) after a median follow-up of 6 months.

The treatment has a very low rate of serious complications (less than 0.1%) and a low rate of surgical retreatment (1.2%), indicating it is a safe option for managing symptoms associated with enlarged prostates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water Vapor Thermal Therapy in Men with Prostate Volume &#8805;80 cm3: A Systematic Review and Meta-Analysis. McVary, KT., Miller, LE., Bhattacharyya, S., et al.[2023]

In a study involving 385 patients with non-castrate metastatic prostate cancer, it was found that physicians significantly under-reported adverse symptoms related to androgen deprivation therapy (ADT), with agreement rates for common symptoms like hot flushes and fatigue being only around 50-64%.

The failure of physicians to report patients' most disturbing symptoms ranged from 50.8% to 89.5%, highlighting the importance of incorporating patients' self-reports in clinical trials to better assess treatment toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15). Gravis, G., Marino, P., Joly, F., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05683691

Study Details | NCT05683691 | Water Vapor Ablation for ... The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason ...

2. urologytimes.com urologytimes.com/view/enrollment-goal-met-in-trial-of-vanquish-device-for-localized-prostate-cancer

Enrollment goal met in trial of Vanquish device for localized ... The VAPOR 2 trial enrolled 235 patients, assessing Vanquish water vapor ablation for intermediate-risk prostate cancer across 26 US sites.

3. francismedical.com francismedical.com/completion-of-vapor-2-enrollment-for-vanquish-prostate-cancer-treatment/

Press Release VAPOR 2 is a prospective, multicenter, single-arm study treating 235 patients with intermediate-risk, localized prostate cancer at 26 US clinical sites.

4. news.keckmedicine.org news.keckmedicine.org/can-you-steam-away-prostate-cancer/

Can you steam away prostate cancer? A water vapor system that uses small, targeted amounts of steam to kill cancer cells is a safe and effective treatment for prostate cancer.

5. healio.com healio.com/news/hematology-oncology/20250305/trial-examines-whether-targeted-steam-can-destroy-prostate-cancer

Trial examines whether targeted steam can destroy ... A national, multisite clinical trial to evaluate a minimally invasive water vapor system that uses steam to treat prostate cancer.

6. francismedical.com francismedical.com/press-release-francis-medical-announces-first-patient-treated-in-vapor2-pivotal-trial/

Press Release: Francis Medical Announces First Patient ... The first patient has been treated in the company's VAPOR 2 pivotal clinical study evaluating the safety and efficacy of its Vanquish minimally invasive water ...

7. mnphy.com mnphy.com/1023-story-one--christopher-dixon

The Vanquish Water Ablation System This pivotal study follows a 15-patient U.S. early feasibility study that demonstrated an excellent safety and efficacy profile, with 14 out of 15 patients ...

8. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2195/prospective-multicenter-single-arm-study/

Prospective Multicenter Single-Arm Study of Vanquish Water ... The purpose of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation Device (“Vanquish”) in subjects with Gleason ...