Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Prostate Cancer Clinical Trial

— PRAPI  

Official title:

Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03496142
• Other study ID #: URO-03-2017
• Status: Not yet recruiting
• Phase: N/A
• First received: April 5, 2018
• Last updated: April 5, 2018
• Start date: April 2018
• Est. completion date: May 2020

Study information

• Verified date: April 2018
• Source: Institut Mutualiste Montsouris
• Contact: Alexandre INGELS, MD
• Phone: 0156616631
• Email: alexandre.ingels[@]imm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Prostate Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of antibiotic resistant germ	Antibiotic resistant germ will be assessed on urinanalysis	One week, two weeks and four weeks post-biopsy
Secondary	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