Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Sponsors

Lead sponsor: Institut Mutualiste Montsouris

Source Institut Mutualiste Montsouris
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.

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.

Overall Status Unknown status
Start Date April 2018
Completion Date May 2020
Primary Completion Date May 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy Four weeks post-biopsy
Secondary Outcome
Measure Time Frame
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
Enrollment 340
Condition
Intervention

Intervention type: Procedure

Intervention name: Transperineal prostate biopsy

Description: 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.

Arm group label: Transperineal prostate biopsy

Intervention type: Procedure

Intervention name: Transrectal prostate biopsy

Description: 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.

Arm group label: Transrectal prostate biopsy

Eligibility

Criteria:

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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Alexandre INGELS, MD Principal Investigator Institut Mutualiste Montsouris
Overall Contact

Last name: Alexandre INGELS, MD

Phone: 0156616631

Email: [email protected]

Location
facility contact Institut Mutualiste Montsouris Alexandre INGELS, MD
Location Countries

France

Verification Date

April 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Transperineal prostate biopsy

Arm group type: Active Comparator

Description: Patient will have a transperineal prostate biopsy.

Arm group label: Transrectal prostate biopsy

Arm group type: Active Comparator

Description: Patient will have a transrectal prostate biopsy.

Acronym PRAPI
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patients who will have prostate biopsy will be randomized 1:1 among transperineal or transrecal approach

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov