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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
December 23, 2015
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
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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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