Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections (PRAPI)

April 5, 2018 updated by: Institut Mutualiste Montsouris

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Post-biopsy infection is becoming a more and more challenging situation due to the increase of incidence and development of antibiotic resistant germs.

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

Patient presenting an indication of prostate biopsy (PSA elevation, suspicious lesion at digital rectal, suspicious lesion on MRI) would be randomized 1:1 among transrectal vs transperineal biopsies.

Post-biopsy infection would be monitored by systemic urine analysis at one, two and four weeks after procedure and in case of clinical symptoms.

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Institut Mutualiste Montsouris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Indication of prostate biopsy

Exclusion Criteria:

  • No indication of prostate biopsy
  • Impossibility for prostate biopsy (e.g. major anal stenosis or history of anal amputation)
  • Antibiotic treatment within three months before prostate biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transperineal prostate biopsy
Patient will have a transperineal prostate biopsy.
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.
Active Comparator: Transrectal prostate biopsy
Patient will have a transrectal prostate biopsy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
Time Frame: Four weeks post-biopsy
Urinary infection will be assessed based on urinanalysis : 10^5 germs and 10^4 leucocytes minimum)
Four weeks post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of antibiotic resistant germ
Time Frame: One week, two weeks and four weeks post-biopsy
Antibiotic resistant germ will be assessed on urinanalysis
One week, two weeks and four weeks post-biopsy
Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication
Time Frame: One week, two weeks and four weeks post-biopsy
Presence of complication will be assessed during phone interview with the patient
One week, two weeks and four weeks post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Mutualiste Montsouris

Investigators

  • Principal Investigator: Alexandre INGELS, MD, Institut Mutualiste Montsouris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URO-03-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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