NCT07339943

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.

Conditions

• Prostate Cancer (Adenocarcinoma)
• Low and Intermediate Risk Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	6 month, prospective, interventional single-arm safety and effectiveness study	x
DEVICE	The TRANBERG|CLS Thermal therapy	Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy

Timeline

• Start date: 2025-04-30
• Primary completion: 2026-05-31
• Completion: 2027-12-31
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: Canada