Viewing Study NCT03996005


Ignite Creation Date: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2026-02-26 @ 12:21 AM
Study NCT ID: NCT03996005
Status: COMPLETED
Last Update Posted: 2025-10-01
First Post: 2019-06-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer
Sponsor: University Hospital, Strasbourg, France
Organization:

Study Overview

Official Title: Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer
Status: COMPLETED
Status Verified Date: 2025-09
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: MRI-TULSAP
Brief Summary: Primary purpose :

Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer.

Primary Objective:

Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.

Secondary Objectives:

1. Biochemical response
2. Presence of any CSC on biopsy at 1- and 2-year follow-up
3. Radical treatment free survival
4. Adverse events, clinical tolerance
5. Urinary continence
6. Erectile function
7. Quality of life
Detailed Description: None

Study Oversight

Has Oversight DMC: False
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?: False
Is an FDA AA801 Violation?: