Transperineal, MRI-guided, Prostate Biopsy
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 prostate-cancer
Started May 2015
Longer than P75 for phase_4 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedDecember 19, 2025
December 1, 2025
8.3 years
December 23, 2015
December 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Collection of complications and rehospitalizations by using questionnaire
12 months
Study Arms (2)
Transperineal prostate biopsy (TPB)
EXPERIMENTALTransperineal prostate biopsy MRI-guided
Transrectal prostate biopsy (TRB)
ACTIVE COMPARATORTransrectal prostate biopsy echo-guided
Interventions
Eligibility Criteria
You may qualify if:
- Men
- 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)
You may not qualify if:
- Gleason \> 6 prostate cancer
- Metastatic prostate cancer
- Contraindication to MRI
- Contraindication to general anesthesia
- Non-reversible hemostasis trouble
- Inability to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'urologie
Strasbourg, 67000, France
Related Publications (1)
Tricard T, Cazzato RL, Poussot B, Gaillard V, Labani A, De Mathelin M, Barhoumi C, Sauleau E, Gangi A, Roy C, Lang H. Transperineal MR Imaging-Guided Prostate Biopsy: A Prospective Randomized Controlled Study on Safety and Effectiveness Compared with Transrectal Biopsy. J Vasc Interv Radiol. 2025 Aug;36(8):1278-1284. doi: 10.1016/j.jvir.2025.05.015. Epub 2025 May 17.
PMID: 40389061RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2015
First Posted
January 11, 2016
Study Start
May 1, 2015
Primary Completion
August 1, 2023
Study Completion
February 1, 2024
Last Updated
December 19, 2025
Record last verified: 2025-12