What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as thermal ablation, radiation therapy, and systemic therapies, have various side effects. Thermal ablation techniques, which include methods like focal laser ablation, can cause mild to moderate side effects such as urinary symptoms, erectile dysfunction, and potential damage to surrounding tissues. Radiation therapy, including image-guided and hypofractionated radiation, may lead to acute gastrointestinal toxicity, urinary symptoms, and a small risk of late toxicity. Systemic therapies, such as the addition of abiraterone to androgen deprivation therapy, can increase the risk of hypertension and hypokalemia. Overall, while these treatments can be effective, they come with a range of potential side effects that should be carefully considered.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include a variety of approaches such as androgen deprivation therapy (ADT), chemotherapy (e.g., docetaxel, cabazitaxel), androgen receptor inhibitors (e.g., enzalutamide, apalutamide, darolutamide), and radiopharmaceuticals (e.g., radium-223). While thermal ablation techniques like high-intensity focused ultrasound (HIFU) are used in some countries, they are not yet standard FDA-approved treatments for prostate cancer. These treatments aim to manage the disease by reducing tumor size, slowing progression, and alleviating symptoms.

What other types of research exist?

Promising novel alternatives to thermal ablation for prostate cancer patients include: 1) Focal Laser Ablation (FLA) using MRI/US image fusion for precise targeting and monitoring of cancerous tissue. 2) Bipolar and convective water vapor thermal therapies, which have shown long-term efficacy in treating benign prostatic hyperplasia and may be adapted for cancer treatment. 3) High-Intensity Focused Ultrasound (HIFU), which uses focused ultrasound waves to destroy cancer cells with minimal damage to surrounding tissues. 4) Prostatic Arterial Embolization (PAE), a minimally invasive procedure that reduces blood flow to the prostate, potentially shrinking tumors. These alternatives offer targeted, minimally invasive options with promising clinical outcomes.

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Procedure

Focal Laser Ablation for Prostate Cancer

N/A

Waitlist Available

Led By Wayne Brisbane, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed adenocarcinoma from targeted biopsy cores

Subjects with organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a laser device called the FocalPoint System, guided by UnfoldAI software, to treat prostate cancer. The software identifies cancer areas using MRI images, and the laser targets and destroys these areas. This method aims to treat men with prostate cancer while protecting nearby healthy structures.

Who is the study for?

Men aged 40-85 with organ-confined prostate cancer (stage ≤ T2b, Gleason score =7), who have a prostate size of 20cc to 80cc and desire focal therapy over conventional treatments. They must have had an MRI showing a suspicious area and confirmed adenocarcinoma from targeted biopsy cores within the last six months.

What is being tested?

The trial is testing the FocalPoint System with UnfoldAI software for treating prostate cancer by using laser ablation guided by MRI/US image fusion. The safety and feasibility are being evaluated through follow-ups including adverse event monitoring and quality-of-life assessments for one year post-treatment.

What are the potential side effects?

While specific side effects are not listed, participants will be monitored for any adverse events following the Focal Laser Ablation treatment during their regular check-ups at various intervals up to one year.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer was confirmed through a biopsy.

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My prostate cancer is contained within the prostate and not severe.

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My prostate size is between 20cc and 80cc.

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I prefer targeted treatment over standard prostate cancer treatments.

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My recent MRI shows a concerning area with a high grade.

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I am between 40 and 85 years old.

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My prostate cancer has a Gleason score of 7.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse event monitoring

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: Arm I TreatmentExperimental Treatment1 Intervention

After inserting the laser, a thermal-optical probe will be inserted via a multichannel needle guide or tranperineal grid in the prostate using transrectal ultrasound guidance. The sensor probe will be placed at a pre-determined depth and location based on the treatment zone. Targets will be identified prior to laser treatment using multi-parametric MRI and delineated by the radiologist for visualization by the treatment operator. The lesion will be visible both on a 3D reconstruction and during real-time ultrasound imaging. Applications of laser energy up to 15 watts of power will be used to treat the target region. Confirmation of appropriate laser position will be made with real-time ultrasound prior to application of laser energy and repeatedly during activation of the laser. Energy delivery will be planned specific to each patient's tumor geometry, with the assistance of the Avenda Health Unfold-AI Software.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focal Laser Ablation

2015

Completed Early Phase 1

~20

0 / 7Eligibility criteria met

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 work through various mechanisms to target and destroy cancerous cells. Ablative therapies, such as thermal ablation, use heat to destroy cancerous tissue, which can be precisely targeted to minimize damage to surrounding healthy tissue. This is particularly relevant for prostate cancer patients as it offers a minimally invasive option with potentially fewer side effects. Radiation therapies, including intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT), use high-energy rays to kill cancer cells by damaging their DNA, which prevents them from growing and dividing. Systemic therapies, such as androgen deprivation therapy (ADT), reduce the levels of male hormones that can promote cancer growth. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the cancer's characteristics and the patient's overall health.

Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.