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Procedure

Focal Laser Ablation for Prostate Cancer

N/A

Recruiting

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

Study Summary

This trial will assess the safety & feasibility of a device used to destroy cancerous tissue in the prostate with thermal energy, and monitor subjects for adverse events & quality of life.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse event monitoring

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,621 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,153 Patients Enrolled for Prostate Cancer

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,030 Total Patients Enrolled

38 Trials studying Prostate Cancer

3,980 Patients Enrolled for Prostate Cancer

Wayne Brisbane, MDPrincipal InvestigatorUniversity of California at Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment capacity of this clinical trial?

"Yes, according to clinicaltrials.gov, the trial began recruitment on September 14th 2023 and has been recently updated in November 16th 2023. As of now, twenty participants are needed for one specific site."

Answered by AI

Who is eligible to be involved in this clinical trial?

"Admittance into this medical trail requires prostate cancer and an age range of 40 to 85. A maximum of 20 people will be allowed in the study."

Answered by AI

Are there any open slots for participants in this clinical trial?

"Per the data on clinicaltrials.gov, this research trial is currently recruiting participants for participation. The study was first posted in September 14th of 2023 and its most recent update was made November 16th of the same year."

Answered by AI

Does this clinical trial accept applicants who are in their mid-forties or older?

"This trial's inclusion criteria mandates that potential participants are between the ages of 40 and 85. There exist 72 clinical trials for those below 18 years old, while 1366 studies accommodate people over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance

2023. "Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047509.