Transperineal, MRI-guided, Prostate Biopsy

February 16, 2024 updated by: University Hospital, Strasbourg, France

Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67000
        • Service d'urologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transperineal prostate biopsy (TPB)
Transperineal prostate biopsy MRI-guided
Procedure: Transrectal prostate biopsy (TRB):
Active Comparator: Transrectal prostate biopsy (TRB)
Transrectal prostate biopsy echo-guided
Procedure: Transperineal, MRI-guided, prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collection of complications and rehospitalizations by using questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimated)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6253

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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