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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03496142
Other study ID # URO-03-2017
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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