Transperineal, MRI-guided, Prostate Biopsy

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Transperineal, MRI-guided, prostate biopsy

• Registration Number: NCT02651948
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Primary purpose:

Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies.

Secondary purposes:

* Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies.

* Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies

* Study of correlation between radiologic images and anatomopathologic result

* Description of needle track during the procedure

* Description of real time template saturation prostate biopsy

* Comparison of transperineal prostate biopsy relevance according to EBM

* Comparison of 1.5T MRI and 3T MRI for prostate cancer detection

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Primary Completion: 2023-08-01
• Study Completion: 2024-02-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transrectal prostate biopsy (TRB)	Transperineal, MRI-guided, prostate biopsy	Transrectal prostate biopsy echo-guided

Primary Outcome Measures

Name	Time	Method
Collection of complications and rehospitalizations by using questionnaire	12 months

Trial Locations

Locations (1)

Service d'urologie; 🇫🇷 Strasbourg, France