Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer (FOCUS-PC)

September 30, 2025 updated by: Albany Medical College

MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For prostate cancer detection, pre-biopsy multi-parametric magnetic resonance imaging (mp-MRI) followed by MRI-targeted prostate biopsy is standard of care which is supported by the guidelines from the American Urological Association and the European Association of Urology. The MRI-targeted prostate biopsy is associated with a significant increase in the detection of clinically significant prostate cancer (csPCa) compared to the ultrasound guided biopsy. The MRI-targeted biopsy can be performed using one of two techniques including software-based fusion of MRI and ultrasound images (software fusion) or visually guided MRI-informed (cognitive fusion) technique.

With regards to the diagnostic performance in detecting csPCa, current literature does not demonstrate a clear advantage to one targeting technique over the other. A systematic review and meta-analysis (published in early 2024) by Falagario et al evaluated all of the comparative studies of the above-mentioned MRI-targeting techniques. Of the 20 studies included, six reported improved detection of csPCa with fusion technique, one reported an advantage to the cognitive technique, while thirteen reported no significant difference. Of note, the majority of the studies were retrospective, with high risk of bias, that lacked uniform definition of csPCa, and employed variable mp-MRI technique (1.5T vs 3T) and scoring system (Likert vs PIRADS). There were only three small, prospective, randomized studies (RCT) available in the systematic review of literature. One RCT reported the fusion technique to be superior while two demonstrated no difference in csPCa detection rates. There was no significant difference in the detection of csPCa between the targeting techniques, however, low quality of evidence and heterogeneity warranted well-designed prospective studies.

Other studies, as well as personal experience, point to somewhat improved cancer detection the cognitive MRI-targeting approach, although the rates may be affected by patient selection related to lesion size and location.

Thus, the investigators are conducting an RCT to direct compare the csPCa detection rates following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on mp-MRI of prostate. The investigators hypothesize that the diagnostic accuracy MRI-targeted prostate biopsy using cognitive fusion technique is either similar to or not significantly inferior to the software fusion technique.

Study Type

Interventional

Enrollment (Estimated)

1306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Badar M Mian, MD
  • Phone Number: 5182623296
  • Email: mianb@amc.edu

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M5
        • Not yet recruiting
        • Manitoba Prostate Centre, CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Ardalanejaz Ahmad, MD
  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Clinic, Inc
        • Contact:
        • Principal Investigator:
          • William Faust, MD
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
          • Badar M. Mian, MD
          • Phone Number: 518-262-7558
          • Email: mianb@amc.edu
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care
  • Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion)
  • Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years
  • Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5
  • Largest dimension of any lesion on mp-MRI to be ≤ 2 cm
  • Prostate-specific antigen level ≤ 20 ng/mL and/or abnormal digital rectal examination

Exclusion Criteria:

  • mp-MRI detected lesions that are > 2 cm
  • History of prostate biopsy within 3 years
  • Previous diagnosis of prostate cancer
  • Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Software fusion biopsy
Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.
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).
Experimental: Cognitive fusion biopy
Cognitive fusion biopsy: Biopsy of the MRI-detected lesion using visual estimation and/or measurements to identify landmarks and lesions.
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).
Other Names:
  • Visual estimation fusion prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of clinically significant prostate cancer
Time Frame: 1 year
Compare the overall detection of clinically significant prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of clinically significant prostate cancer in the targeted cores, systematic biopsy cores, and combined
Time Frame: 1 year
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year
Detection of clinically significant prostate cancer based on lesion size (< 0.5 cm; 0.5 cm to 1 cm; > 1.1 cm etc)
Time Frame: 1 year
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year
Detection of clinically significant prostate cancer at various lesion location (anterior, posterior, apex, base)
Time Frame: 1 year
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year
Detection rate of overall prostate cancer of any grade
Time Frame: 1 year
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year
Detection rate of clinically insignificant (low grade) prostate cancer
Time Frame: 1 year
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year
Detection rate of clinically significant prostate cancer based on PSA density (PSA level / prostate volume)
Time Frame: 1 year
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Investigators

  • Study Chair: Badar M Mian, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7028 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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