NCT06517901 Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
| NCT ID | NCT06517901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albany Medical College |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,306 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,306 participants in total. It began in 2025-04-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Badar M Mian, MD
STUDY CHAIR
Albany Medical College
Frequently Asked Questions
Who can join the NCT06517901 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06517901 currently recruiting?
Yes, NCT06517901 is actively recruiting participants. Contact the research team at mianb@amc.edu for enrollment information.
Where is the NCT06517901 trial being conducted?
This trial is being conducted at Burlington, United States, Albany, United States, Hershey, United States, Winnipeg, Canada.
Who is sponsoring the NCT06517901 clinical trial?
NCT06517901 is sponsored by Albany Medical College. The principal investigator is Badar M Mian, MD at Albany Medical College. The trial plans to enroll 1,306 participants.
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