Targeted microwave ablation for prostate cancer (FOSTINE1b): a prospective 'ablate-and-resect' study

Area of Science:

• Urology
• Oncology
• Medical Devices

Background:

• Localized prostate cancer (PCa) necessitates effective and minimally invasive treatment options.
• The Trinity system offers targeted microwave ablation (TMA) as a potential therapeutic approach.

Purpose of the Study:

• To evaluate the histopathological outcomes, feasibility, and safety of TMA using the Trinity system for localized PCa.
• To assess functional outcomes and adverse events associated with the procedure.

Main Methods:

• A prospective, single-institution, interventional Phase IIa study with an 'ablate-and-resect' design.
• 11 patients with localized PCa underwent transrectal TMA under conscious sedation.
• Magnetic resonance imaging (MRI) and robot-assisted radical prostatectomy (RARP) were performed post-ablation.

Main Results:

• TMA was successfully performed as an outpatient procedure with no same-day discharges.
• No severe adverse events (Grade ≥3) or decline in urinary/sexual function were reported.
• Histopathology confirmed complete necrosis of the ablation zone when using power intensity >10W; MRI and surgical specimen volumes correlated.
• RARP was uncomplicated, with no intraoperative complications.

Conclusions:

• Targeted microwave ablation via the Trinity system is a secure and feasible treatment for localized PCa.
• Complete necrosis within the ablation zone was histopathologically confirmed, supporting the efficacy of TMA.