RecruitingNot ApplicableNCT07339943

Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness

Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness


Sponsor

University Health Network, Toronto

Enrollment

7 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive treatment for intermediate-risk prostate cancer called focal laser ablation — where a laser is used to destroy only the part of the prostate containing the tumour, guided by a new high-resolution micro-ultrasound system. The aim is to treat the cancer effectively while protecting urinary and sexual function. **You may be eligible if...** - You are a man aged 40–80 - You have intermediate-risk prostate cancer confirmed by biopsy (Gleason score 7 / ISUP Grade 2–3) - Your cancer is limited to one side of the prostate and the tumour is 15 mm or smaller on imaging - Your cancer stage is T1c or T2 - Your PSA level is below 15 ng/mL - You have a life expectancy of more than 10 years **You may NOT be eligible if...** - Your tumour is larger than 15 mm - You have previously had prostate surgery, radiation, hormone therapy, or other treatments like HIFU or cryotherapy for prostate cancer - You are not well enough for focal therapy - You have declined to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURE6 month, prospective, interventional single-arm safety and effectiveness study

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DEVICEThe TRANBERG|CLS Thermal therapy

Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy


Locations(1)

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT07339943


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