An interventional study of Transperineal prostate biopsy and Transrectal prostate biopsy in Prostate Cancer, sponsored by Institut Mutualiste Montsouris. Status unknown at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Institut Mutualiste Montsouris · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Patient will have a transperineal prostate biopsy.
Procedure: Transperineal prostate biopsy
Patient will have a transrectal prostate biopsy.
Procedure: Transrectal 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.
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.
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)
Time frame: Four weeks post-biopsy
Presence of antibiotic resistant germ
Antibiotic resistant germ will be assessed on urinanalysis
Time frame: One week, two weeks and four weeks post-biopsy
Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication
Presence of complication will be assessed during phone interview with the patient
Time frame: One week, two weeks and four weeks post-biopsy
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Institut Mutualiste Montsouris