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

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

This study will test whether MRI-targeted biopsy using software fusion or cognitive (visual) fusion finds more clinically significant prostate cancer in men with suspicious mp‑MRI lesions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1306 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Albany Medical College (Academic / other)
• Locations: 4 sites (Burlington, Massachusetts and 3 other locations)
• Trial ID: NCT06517901 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men scheduled for prostate biopsy who have a recent mp‑MRI showing one or more PIRADS 3–5 lesions ≤2 cm, PSA ≤20 ng/mL, and no prostate biopsy within the past 3 years.

Not a fit: Men with prior prostate cancer, a prostate biopsy within the last 3 years, MRI lesions larger than 2 cm, or medical contraindications to biopsy are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If one technique clearly finds more clinically significant cancers, clinicians could adopt that approach to improve diagnostic accuracy and reduce missed cancers.

How similar studies have performed: Existing literature is mixed—many retrospective series and only a few small randomized trials have not established a clear advantage for fusion over cognitive targeting.

Eligibility criteria

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 this trial is running

Burlington, Massachusetts and 3 other locations

• 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

Conditions Prostate Cancer; Diagnosis; Prostate; Cancer; Biopsy; MRI