Transperineal, MRI-guided, Prostate Biopsy

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02651948
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 87
• Patients Per Site Per Month: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Transperineal, MRI-guided, prostate biopsy; Procedure: Transrectal prostate biopsy (TRB):	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer
• Actual Study Start Date: May 1, 2015
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transperineal prostate biopsy (TPB) Transperineal prostate biopsy MRI-guided	Procedure: Transrectal prostate biopsy (TRB):
Active Comparator: Transrectal prostate biopsy (TRB) Transrectal prostate biopsy echo-guided	Procedure: Transperineal, MRI-guided, prostate biopsy

Outcome Measures

Primary Outcome Measures

1. Collection of complications and rehospitalizations by using questionnaire [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'urologie	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02651948
• Other Study ID Numbers: 6253
• First Posted: Jan 11, 2016
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Aug 19, 2022