NCT04278261

Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer

A Prospective, Single-center, Randomized Controlled Trial Comparing the Functional and Oncological Outcomes of High-frequency Irreversible Electroporation and Laparoscopic Radical Prostatectomy in Men With Localized Prostate Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: Male
• Age: 80 Years
• Healthy volunteers: Accepted

Summary

This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.

Detailed description

Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.

Conditions

• Prostate Cancer
• Treatment

Interventions

Type	Name	Description
PROCEDURE	Focal therapy(high-frequency irreversible electroporation)	High-frequency irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer
PROCEDURE	laparoscopic radical prostatectomy	Laparoscopic radical prostatectomy

Timeline

• Start date: 2022-07-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2020-02-20
• Last updated: 2022-06-02

Locations

1 site across 1 country: China