Recruiting

Cognitive vs. FusionFusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Sponsor:

Albany Medical College

Code:

NCT06517901

Conditions

Prostate Cancer

Diagnosis

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Software fusion prostate biopsy

Cognitive fusion prostate biopsy

Study Details

Brief 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

Prostate Cancer

Diagnosis

Study ID

NCT06517901

Start date

Apr 18, 2025

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Software fusion biopsy

Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.

experimental: Cognitive fusion biopy

Cognitive fusion biopsy: Biopsy of the MRI-detected lesion using visual estimation and/or measurements to identify landmarks and lesions.

Interventions

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).

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).

Primary outcome measure

Detection of clinically significant prostate cancer [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Badar M Mian, MD

5182623296 mianb@amc.edu

Locations

Lahey Clinic, Inc

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Kimberly Rieger-Christ

781-744-8027 bilh_osr@lahey.org

Principal Investigator:

William Faust, MD

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Badar M. Mian, MD

518-262-7558 mianb@amc.edu

Brenda Romeo

518-262-8579 romeob@amc.edu

More Information

Sponsor

Albany Medical College

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Keywords

Prostate
Cancer
Biopsy
Diagnosis
MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2025-10-03.