Transperineal, MRI-guided, Prostate Biopsy

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Service d'urologie

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transperineal, MRI-guided, prostate biopsy

Procedure

Transrectal prostate biopsy (TRB):

Procedure

Primary outcomes

Collection of complications and rehospitalizations by using questionnaire

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2023
Study completion: 2024
First posted: Jan 11, 2016
Registry last updated: Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed