NCT06262633

A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer

A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.

Detailed description

This is a prospective multi-centre trial in 5 hospitals in 3 countries to investigate the efficacy and complications of targeted Microwave Ablation as a minimally invasive focal therapy for prostate cancer. Men aged 50-75 with PSA \< 20ng/mL and clinically significant prostate cancer with 1-2 MRI lesions ≤15mm and ISUP grade group ≤3 will be recruited. Transperineal targeted Microwave Ablation of the prostate tumor(s) will be done with repeated ablations by a single microwave needle guided by MRI-Ultrasound fusion and organ-based tracking navigation. The primary outcome is any clinically significant prostate cancer detected on biopsy of treated area(s) per patient at 6 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation	Targeted microwave ablation (TMA) is a novel treatment developed for focal treatment of prostate cancer, and it is applied with precise navigation guidance under the organ-based tracking (OBT) mechanism.

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2024-02-16
• Last updated: 2025-05-06

Locations

1 site across 1 country: Hong Kong