What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as ablative therapies, radiation therapies, and surgical treatments, have various side effects. Ablative therapies, including water vapor ablation, are still under research, and their side effects are not well-documented. Radiation therapies, such as image-guided radiation therapy (IGRT) and hypofractionated radiation therapy, can cause acute gastrointestinal toxicity and, in some cases, late toxicity. Surgical treatments, like transurethral resection of the prostate (TURP) and laser vaporization, may lead to complications such as urinary incontinence and erectile dysfunction. Overall, more research is needed to fully understand the side effects of newer ablative techniques like water vapor ablation.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including systemic therapies and localized treatments. Systemic therapies include androgen deprivation therapy (ADT), androgen receptor inhibitors like enzalutamide and abiraterone, and chemotherapeutic agents such as docetaxel. Localized treatments for prostate cancer, which are more similar to the Vanquish Water Vapor Ablation Device, include surgical options like prostatectomy and minimally invasive procedures such as transurethral resection of the prostate (TURP) and laser therapies. These treatments aim to target and eliminate cancer cells within the prostate while minimizing damage to surrounding tissues.

What other types of research exist?

Promising novel alternatives to the Vanquish Water Vapor Ablation Device for prostate cancer treatment include: <ol> <li>Stereotactic Body Radiotherapy (SBRT) - A precise form of radiation therapy that delivers high doses of radiation to the tumor while minimizing damage to surrounding tissues.</li> <li></li> </ol> High-Intensity Focused Ultrasound (HIFU) - A non-invasive technique that uses focused ultrasound waves to heat and destroy cancer cells. 3. Focal Laser Ablation - Uses laser energy to target and destroy cancerous tissue with minimal impact on surrounding healthy tissue. 4. Immunotherapy - Treatments like Sipuleucel-T (Provenge) that stimulate the body's immune system to attack prostate cancer cells. 5. Targeted Therapy - Drugs that specifically target cancer cell mechanisms, such as PARP inhibitors for patients with specific genetic mutations.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

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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.