Transperineal, MRI-guided, Prostate Biopsy

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02651948

Enrollment

Registered

2016-01-11

Start date

2015-05-01

Completion date

2024-02-01

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

Interventions

PROCEDURETransperineal, MRI-guided, prostate biopsy

PROCEDURETransrectal prostate biopsy (TRB):

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Collection of complications and rehospitalizations by using questionnaire	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026