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

Institut Mutualiste Montsouris

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: Transperineal prostate biopsy; Procedure: Transrectal prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03496142

URO-03-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Transperineal prostate biopsy

Active Comparator group

Description:

Patient will have a transperineal prostate biopsy.

Treatment:

Procedure: Transperineal prostate biopsy

Transrectal prostate biopsy

Active Comparator group

Description:

Patient will have a transrectal prostate biopsy.

Treatment:

Procedure: Transrectal prostate biopsy