Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

Prostate Cancer Clinical Trial

Official title: Clinical Validation of Transrectal Multiparametric Ultrasound Imaging Strategy (PCaVision) for the Detection of Clinically Significant Prostate Cancer: a Head-to-head Comparison With the MRI-based Strategy

Status Recruiting

Clinical Trial Summary

The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).

Clinical Trial Description

All patients will undergo imaging using MRI and PCaVision during which suspicious lesions will be identified based on each imaging technique independently with readers being blinded for the results of the other imaging technique. Thereafter, a MRI targeted 3-core biopsy per lesion (maximum of 2 lesions) and/ or a PCaVision targeted 3-core biopsy (maximum of 2 lesions) will be performed by a one physician if suspicious lesions have been identified based on imaging. If lesions have been identified with both PCaVision and MRI in the same patient, the order of the targeted biopsies will be randomized. If the same lesion has been identified on both MRI and PCaVision, both a MRI-targeted and a PCaVision targeted biopsy will be separately performed. Histological examination of the targeted biopsies will be performed to determine presence of clinically significant prostate cancer. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06281769
• Study type: Interventional
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Daniel van den Kroonenberg, MD
• Phone: 310639345375
• Email: d.kroonenbergvanden@amsterdamumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Completion date: January 1, 2025