Software fusion versus cognitive (visual) MRI-guided ultrasound biopsy for prostate cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multi-center trial assigns men with suspicious mp‑MRI prostate lesions (PIRADS 3–5) to undergo MRI-targeted biopsy using either software-based image fusion or cognitive (visual) MRI-guided targeting. Participants must have pre-biopsy mp‑MRI with lesions ≤2 cm, PSA ≤20 ng/mL, and no prostate biopsy within the previous 3 years; biopsies may be performed transrectally or transperineally per routine care. The primary outcome is the detection rate of clinically significant prostate cancer, using standardized pathology definitions across sites. The trial is designed to provide adequately powered randomized evidence to clarify whether one targeting method improves clinically meaningful cancer detection compared with the other.

Why it matters

Who can join: the full rules

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)

Where it's running

• Lahey Clinic, Inc
  Burlington, Massachusetts, United States Recruiting
• Albany Medical Center
  Albany, New York, United States Recruiting
• Pennsylvania State University
  Hershey, Pennsylvania, United States Not yet recruiting
• Manitoba Prostate Centre, CancerCare Manitoba
  Winnipeg, Manitoba, Canada Not yet recruiting

Study contacts

• Study coordinator: Badar M Mian, MD
• Email: mianb@amc.edu
• Phone: 5182623296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.