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Thermal Ablation

Focal Laser Ablation for Prostate Cancer

Phase < 1

Waitlist Available

Led By Allan Pantuck, M.D.

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

Subjects with untreated, organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7) aged 40 to 85 years

Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery, and hormone therapy)

Must not have

Any prior treatment for prostate cancer including radical prostatectomy, radiation therapy, cryotherapy, high-intensity focused ultrasound (HIFU) treatment, photodynamic therapy, androgen deprivation therapy, prior prostate, bladder neck, or urethral stricture surgery, any prostate debulking procedure, transurethral incision of bladder neck, urethral stricture dilation or reconstruction, use of 5-alpha reductase inhibitors within 6 months of treatment, prior significant rectal surgery (hemorrhoidectomy is acceptable), rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device, inflammatory bowel disease, urinary tract or rectal fistula, previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery, any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)

Any medical condition that would compromise the subject's ability to safely participate including active bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from treatment at 1 week, 1 month, and every 3 months until one year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, minimally invasive way to treat prostate cancer using heat. The goal is to see if it is safe and effective.

Who is the study for?

Men aged 40-85 with untreated, organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7), who have had a recent MRI and biopsy confirming the diagnosis. They should want focal therapy over conventional treatments and have a prostate size between 20cc to 80cc. Excluded are those with bleeding disorders, on anticoagulants that can't be stopped, prior prostate cancer treatments, significant rectal or urinary conditions, or contraindications to MRI.

What is being tested?

The trial is testing the safety and feasibility of using MR-ultrasound fusion-guided Focal Laser Ablation (FLA) for treating prostate cancer with the Orion System. This method aims at precisely targeting and destroying cancerous tissue in the prostate while sparing healthy areas.

What are the potential side effects?

Potential side effects may include discomfort from the procedure itself, risks associated with laser ablation such as damage to surrounding tissues leading to urinary or sexual dysfunction, infection risk due to transrectal device insertion, and typical adverse reactions related to any invasive treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am between 40 to 85 years old with early-stage prostate cancer.

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I prefer targeted treatment over standard prostate cancer treatments.

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My biopsy shows I have a specific type of prostate cancer with a Gleason score of 7.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any previous treatments or surgeries for prostate cancer that would interfere with new treatments.

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I do not have any health conditions that would make it unsafe for me to join.

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I have no significant cancer outside the treatment area with a Gleason score under 7 and expect to live more than 10 years.

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I currently have a urinary tract infection, prostate issues, or bladder control problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment at 1 week, 1 month, and every 3 months until one year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment at 1 week, 1 month, and every 3 months until one year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment at 1 week, 1 month, and every 3 months until one year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety based on cumulative adverse events incurred

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: Focal Laser AblationExperimental Treatment1 Intervention

The Orion system will be used to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy.

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