Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

NCT03496142 | Unknown DMC

• 1 other identifier: URO-03-2017
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate biopsy approach; Transrectal prostate biopsy; Transperineal prostate biopsy; Iatrogenic infection; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Presence of antibiotic resistant germ

  One week, two weeks and four weeks post-biopsy

• Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication

  One week, two weeks and four weeks post-biopsy

Study Arms (2)

Transperineal prostate biopsy

ACTIVE COMPARATOR

Patient will have a transperineal prostate biopsy.

Procedure: Transperineal prostate biopsy

Transrectal prostate biopsy

ACTIVE COMPARATOR

Patient will have a transrectal prostate biopsy.

Procedure: Transrectal prostate biopsy

Interventions

Transperineal prostate biopsy PROCEDURE

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.

Transperineal prostate biopsy

Transrectal prostate biopsy PROCEDURE

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.

Transrectal prostate biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of prostate biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alexandre INGELS, MD

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre INGELS, MD

CONTACT

0156616631; alexandre.ingels@imm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who will have prostate biopsy will be randomized 1:1 among transperineal or transrecal approach

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: April 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)