NCT06517901 · Albany Medical College
Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
(FOCUS-PC)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Burlington, Massachusetts
- Albany, New York
- Hershey, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations