Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SC 3065 | Other Identifier | CPP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.
The act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which are both done in current practice.
Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted biopsies guided by a fusion of MRI and ultrasound | Other | After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system |
|
| Systematic biopsies | Other | The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systematic biopsies | Procedure | 90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carcinomatous invasion on biopsies samples | The presence of carcinomatous invasion on biopsies samples | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue length of biopsy invaded by the detected cancer | Maximal tissue length of biopsy invaded by the detected cancer | Day 15 |
| Biopsy Gleason score of the detected cancer | Maximal biopsy Gleason score of the detected cancer |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| François Cornud, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble | Grenoble | 38043 | France | |||
| Chu Edouard Herriot |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27079582 | Result | Delongchamps NB, Portalez D, Bruguiere E, Rouviere O, Malavaud B, Mozer P, Fiard G, Cornud F; MURIELLE Study Group. Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer? J Urol. 2016 Oct;196(4):1069-75. doi: 10.1016/j.juro.2016.04.003. Epub 2016 Apr 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Targeted biopsies guided by a fusion of MRI and ultrasound- images | Procedure | Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system |
|
|
| Day 15 |
| Respective duration of each biopsy protocol | Day 0 |
| Lyon |
| 69437 |
| France |
| CHU Pitié salpêtrière | Paris | 75013 | France |
| CHU Cochin | Paris | 75014 | France |
| CHU Toulouse Rangueil | Toulouse | 31076 | France |
| Clinique Pasteur | Toulouse | 31076 | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided