NCT06212453

Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Detailed description

Transurethral resection of the prostate, laser vaporization or enucleation, and simple open prostatectomy represent the current gold standard surgical interventions for BPH-related obstruction. However, these treatments are burdened by their invasiveness, intra and post-operative morbidity, and long-term complications, including ejaculatory dysfunction (70%), urethral strictures (7%), urinary incontinence (2%), and bleeding. Laser-based surgical strategies have only partially overcome these drawbacks. To provide a personalized therapy for the treatment of BPH related-symptoms, several minimally invasive surgical therapies (MISTs) were developed with the aim of achieving outcomes comparable to the gold standard invasive procedures while minimizing SD and other complications. Urolift implants and Rezum system have demonstrated less complication rate and hospitalization time than standard surgeries. Recently, 3D ultrasound-guided transperineal focal microwave ablation (TMA) was developed as a focal treatment for localized prostate cancer. Ultrasound-MRI image fusion was performed with organ-based tracking-registration using KOELIS Trinity™ (Koelis, Meylan, France). Microwave thermal ablation was provided by the TATO generator (Biomedical Srl, Firenze, Italy) using a single 17G needle inserted transperineally. This treatment was reported to be safe, precise, and feasible in an outpatient setting.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Targeted Microwave Ablation	3D ultrasound-guided focal thermal ablation of the prostate transition zone

Timeline

• Start date: 2024-04-24
• Primary completion: 2025-04-01
• Completion: 2026-08-01
• First posted: 2024-01-18
• Last updated: 2025-01-20

Locations

1 site across 1 country: France