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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transperineal prostate biopsy | Active Comparator | Patient will have a transperineal prostate biopsy. |
|
| Transrectal prostate biopsy | Active Comparator | Patient will have a transrectal prostate biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transperineal prostate biopsy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of antibiotic resistant germ | Antibiotic resistant germ will be assessed on urinanalysis | One week, two weeks and four weeks post-biopsy |
| Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre INGELS, MD | Contact | 0156616631 | alexandre.ingels@imm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre INGELS, MD | Institut Mutualiste Montsouris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Mutualiste Montsouris | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patients who will have prostate biopsy will be randomized 1:1 among transperineal or transrecal approach
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| Transrectal prostate biopsy | Procedure | 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. |
|
Presence of complication will be assessed during phone interview with the patient
| One week, two weeks and four weeks post-biopsy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |