Transperineal, MRI-guided, Prostate Biopsy
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Transperineal, MRI-guided, prostate biopsy
Transrectal prostate biopsy (TRB):
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion criteria:
- Men
- 40 to 80 years' old
- Affiliation to French social health system
- Signed consent
- Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies
- Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA < 10)
Exclusion criteria:
- Gleason > 6 prostate cancer
- Metastatic prostate cancer
- Contraindication to MRI
- Contraindication to general anesthesia
- Non-reversible hemostasis trouble
- Inability to give consent
Sites / Locations
- Service d'urologieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transperineal prostate biopsy (TPB)
Transrectal prostate biopsy (TRB)
Arm Description
Transperineal prostate biopsy MRI-guided
Transrectal prostate biopsy echo-guided
Outcomes
Primary Outcome Measures
Collection of complications and rehospitalizations by using questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02651948
First Posted
December 23, 2015
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02651948
Brief Title
Transperineal, MRI-guided, Prostate Biopsy
Official Title
Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary purpose:
Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies.
Secondary purposes:
Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies.
Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies
Study of correlation between radiologic images and anatomopathologic result
Description of needle track during the procedure
Description of real time template saturation prostate biopsy
Comparison of transperineal prostate biopsy relevance according to EBM
Comparison of 1.5T MRI and 3T MRI for prostate cancer detection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transperineal prostate biopsy (TPB)
Arm Type
Experimental
Arm Description
Transperineal prostate biopsy MRI-guided
Arm Title
Transrectal prostate biopsy (TRB)
Arm Type
Active Comparator
Arm Description
Transrectal prostate biopsy echo-guided
Intervention Type
Procedure
Intervention Name(s)
Transperineal, MRI-guided, prostate biopsy
Intervention Type
Procedure
Intervention Name(s)
Transrectal prostate biopsy (TRB):
Primary Outcome Measure Information:
Title
Collection of complications and rehospitalizations by using questionnaire
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Men
40 to 80 years' old
Affiliation to French social health system
Signed consent
Prostate cancer suspicion based on prostate specific antigen (PSA) or digital rectal exam WITH abnormal MRI (Prostate Imaging Reporting and Data System score 3) AND negative transrectal prostate biopsies
Patient treated by active surveillance for a low risk prostate cancer (T1c or T2a, Gleason = 6, PSA < 10)
Exclusion criteria:
Gleason > 6 prostate cancer
Metastatic prostate cancer
Contraindication to MRI
Contraindication to general anesthesia
Non-reversible hemostasis trouble
Inability to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lang Hervé, MD
Email
herve.lang@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Tricard Thibault
Email
thibault.tricard@chru-strasbourg.fr
Facility Information:
Facility Name
Service d'urologie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé Lang, MD
Email
herve.lang@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Transperineal, MRI-guided, Prostate Biopsy
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