Back to results

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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Transperineal prostate biopsy

Transrectal prostate biopsy

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate biopsy approach, Transrectal prostate biopsy, Transperineal prostate biopsy, Iatrogenic infection, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Institut Mutualiste Montsouris

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Transperineal prostate biopsy

Transrectal prostate biopsy

Arm Description

Patient will have a transperineal prostate biopsy.

Patient will have a transrectal prostate biopsy.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Presence of antibiotic resistant germ

Antibiotic resistant germ will be assessed on urinanalysis

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

Presence of complication will be assessed during phone interview with the patient

Full Information

NCT ID

NCT03496142

First Posted

April 5, 2018

Last Updated

April 5, 2018

Sponsor

Institut Mutualiste Montsouris

1. Study Identification

Unique Protocol Identification Number

NCT03496142

Brief Title

Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Acronym

PRAPI

Official Title

Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2018 (Anticipated)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Mutualiste Montsouris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transperineal prostate biopsy

Arm Type

Active Comparator

Arm Description

Patient will have a transperineal prostate biopsy.

Arm Title

Transrectal prostate biopsy

Arm Type

Active Comparator

Arm Description

Patient will have a transrectal prostate biopsy.

Intervention Type

Procedure

Intervention Name(s)

Transperineal prostate biopsy

Intervention 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.

Intervention Type

Procedure

Intervention Name(s)

Transrectal prostate biopsy

Intervention 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.

Primary Outcome Measure Information:

Title

Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy

Description

Urinary infection will be assessed based on urinanalysis : 10^5 germs and 10^4 leucocytes minimum)

Time Frame

Four weeks post-biopsy

Secondary Outcome Measure Information:

Title

Presence of antibiotic resistant germ

Description

Antibiotic resistant germ will be assessed on urinanalysis

Time Frame

One week, two weeks and four weeks post-biopsy

Title

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

Description

Presence of complication will be assessed during phone interview with the patient

Time Frame

One week, two weeks and four weeks post-biopsy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandre INGELS, MD

Phone

0156616631

alexandre.ingels@imm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre INGELS, MD

Organizational Affiliation

Institut Mutualiste Montsouris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Mutualiste Montsouris

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre INGELS, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

We'll reach out to this number within 24 hrs