Prostate Cancer
Conditions
Keywords
Prostate biopsy approach, Transrectal prostate biopsy, Transperineal prostate biopsy, Iatrogenic infection, Prevention
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.
Interventions
PROCEDURETransperineal 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.
PROCEDURETransrectal 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.
Sponsors
Institut Mutualiste Montsouris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients who will have prostate biopsy will be randomized 1:1 among transperineal or transrecal approach
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy | Four weeks post-biopsy | Urinary infection will be assessed based on urinanalysis : 10\^5 germs and 10\^4 leucocytes minimum) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of antibiotic resistant germ | One week, two weeks and four weeks post-biopsy | Antibiotic resistant germ will be assessed on urinanalysis |
| Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication | One week, two weeks and four weeks post-biopsy | Presence of complication will be assessed during phone interview with the patient |
Countries
France
Contacts
Primary ContactAlexandre INGELS, MD
Outcome results
None listed