Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
Study NCT ID:
NCT04278261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-06-02
First Post:
2020-02-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer
Sponsor:
Shanghai East Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: