NCT06517901Recruiting
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1306 (estimated)
- First submitted
- 19 Jul 2024
- Start date
- 18 Apr 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Albany Medical College
- Diseases
- Prostate cancer
- NCT number
- NCT06517901
What you commit to
- Study type: Interventional
- Planned participants: 1306
- From 18 Apr 2025 to the primary completion date, 31 Dec 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of prostate cancer
Other illness
- History of prostate biopsy within 3 years
- Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)
Other
- mp-MRI detected lesions that are \> 2 cm
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Manitoba Prostate Centre CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Not yet recruiting |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Lahey Clinic, Inc Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| Pennsylvania State University Coordinator of this site? Confirm its status | Hershey | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.