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

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: Prostate Cancer
• Intervention / Treatment: Procedure: Transperineal prostate biopsy; Procedure: Transrectal prostate biopsy

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

• Study Contact: Name: Alexandre INGELS, MD; Phone Number: 0156616631; Email: alexandre.ingels@imm.fr

Study Locations

• France
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
    • Contact: Alexandre INGELS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Presence of complication will be assessed during phone interview with the patient	One week, two weeks and four weeks post-biopsy

Collaborators and Investigators

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

Study record dates

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: Prevention; Prostate biopsy approach; Transrectal prostate biopsy; Transperineal prostate biopsy; Iatrogenic infection
• Additional Relevant MeSH Terms: Infections
• 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