Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Part of paid clinical trials in Burlington, Massachusetts.

Sponsor
Albany Medical College
Study ID
NCT06517901
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Software fusion prostate biopsy — PROCEDURE
    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 — PROCEDURE
    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).

Study Details

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.

Key Dates

Start date
Apr 18, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
1,306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lahey Clinic, IncBurlingtonMassachusetts01805
Kimberly Rieger-Christ
[email protected]
781-744-8027
William Faust, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CenterAlbanyNew York12208
Badar M. Mian, MD
[email protected]
518-262-7558
Brenda Romeo
[email protected]
518-262-8579
Pennsylvania State UniversityHersheyPennsylvania17023
Suzanne Boltz
[email protected]
717-531-0003
Jay Raman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Burlington, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Lahey Clinic, Inc· Burlington, MAAlbany Medical Center· Albany, NYPennsylvania State University· Hershey, PA

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