Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2015-05-01
2024-02-01
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Transperineal prostate biopsy (TPB)
Transperineal prostate biopsy MRI-guided
Transrectal prostate biopsy (TRB):
Transrectal prostate biopsy (TRB)
Transrectal prostate biopsy echo-guided
Transperineal, MRI-guided, prostate biopsy
Interventions
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Transperineal, MRI-guided, prostate biopsy
Transrectal prostate biopsy (TRB):
Eligibility Criteria
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Inclusion Criteria
* 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
* Metastatic prostate cancer
* Contraindication to MRI
* Contraindication to general anesthesia
* Non-reversible hemostasis trouble
* Inability to give consent
40 Years
80 Years
MALE
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Service d'urologie
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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6253
Identifier Type: -
Identifier Source: org_study_id