NCT03819751

MRI-targeted Biopsy of the Prostate: Software Versus Visual Registration in the Accuracy of Prostate Cancer Detection

MRI-targeted Biopsy of the Prostate: a Prospective Comparison of Software-based Fusion Versus Visual (Cognitive) Registration in the Accuracy of Clinically Significant Prostate Cancer Detection

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

With the general acceptance of MRI and technical advances in biopsy technique of the prostate, new questions arise concerning the selection of patients, the approach, the appropriate technique, the lesions to target and the number of biopsies. The purpose of this study is to address these issues in men suspicious of having prostate cancer and without prior biopsies.

Detailed description

Trial Design: This is a prospective, single center, comparative, diagnostic study of two biopsy techniques. All men aged 50 to 75 years with clinical suspicion of PCa (elevated prostate specific antigen (PSA) levels in blood and/or abnormal digital rectal examination) and an MRI with suspicious lesion(s) (presence of PI-RADS 3-5 lesion) will be included. Participants receive both types of biopsy, but will be randomized concerning the order of the biopsy. All men will also receive traditional systematic biopsies. Treatment and further follow-up is according to EAU guidelines. Data of treatment and follow-up will be retrieved till 2 years after initial MRI-visit. Sample Size: Based on McNemar test for the comparison between the accuracy of the two biopsy techniques, the required sample size is estimated on 96 patients. Assessment of efficacy: Efficacy of software and visual registration biopsy will be determined by histopathology: cancer core length (actual length and percentage) and comparison with systematic biopsy as reference standard. Direct access to source data and documents: The investigator(s) and the institution(s) will permit trial-related monitoring, audits, EC review, and regulatory inspections (where appropriate) by providing direct access to source data and other documents (i.e. patients' case sheets, blood test reports, X-ray reports, histology reports, etc.). Data handling and management: All data collected during the study remain confidential and according to the GDPR regulation. Data of the participants will be retrieved from their electronic patient files. Each participant will be given a unique identification number. When data are coded, there continues to be a link between the data and the individual who provided it. The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. The subject's name or other identifiers should be stored separately (site file) from their research data and replaced with a unique code to create a new identity for the subject. Note that coded data are not anonymous. All data is collected and stored electronically by the principal investigator and co-investigators.

Conditions

• Prostate Cancer
• Prostate Neoplasm

Interventions

Type	Name	Description
PROCEDURE	MRI-targeted prostate biopsy	All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)

Timeline

• Start date: 2019-03-18
• Primary completion: 2025-02-01
• Completion: 2025-07-01
• First posted: 2019-01-28
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium