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Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

NCT03496142 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2018-04-12

No results posted yet for this study

Summary

Retrospective reports from literature have shown a lower rate of infections for transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.

The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.

Conditions

Interventions

PROCEDURE

Transperineal prostate biopsy

Puncture of 12 to 30 percutaneous prostate core biopsies through the perineum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.

PROCEDURE

Transrectal prostate biopsy

Patient would undergo 12 to 30 transrectal prostate core biopsies through the rectum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.

Sponsors & Collaborators

  • Institut Mutualiste Montsouris

    lead OTHER

Principal Investigators

  • Alexandre INGELS, MD · Institut Mutualiste Montsouris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03496142 on ClinicalTrials.gov