Transperineal, MRI-guided, Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651948
• Other study ID #: 6253
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2015
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Transperineal, MRI-guided, prostate biopsy

• Transrectal prostate biopsy (TRB):

Locations

Country	Name	City	State
France	Service d'urologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of complications and rehospitalizations by using questionnaire		12 months