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Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

NCT06517901 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1306

Last updated 2025-10-03

No results posted yet for this study

Summary

The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:

1. Software-based fusion of MRI and ultrasound images (software fusion) or
2. Visually estimated MRI-informed (cognitive fusion) technique

To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.

Conditions

Interventions

PROCEDURE

Software fusion prostate biopsy

Software fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).

PROCEDURE

Cognitive fusion prostate biopsy

Cognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and/or measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Badar M Mian, MD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517901 on ClinicalTrials.gov