Biopsy Techniques for Prostate Cancer Detection
(FOCUS-PC Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Cognitive fusion prostate biopsy, Software fusion prostate biopsy for prostate cancer detection?
Is cognitive fusion prostate biopsy safe for humans?
How does cognitive and software fusion prostate biopsy differ from other treatments for prostate cancer detection?
Cognitive and software fusion prostate biopsies are unique because they combine ultrasound and MRI images to better target suspicious areas in the prostate, improving the accuracy of cancer detection compared to standard biopsy methods. Cognitive fusion is a simpler and more cost-effective alternative to computer-assisted fusion, making it more accessible while still enhancing the detection of clinically significant prostate cancer.12369
What is the purpose of this trial?
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) or2. Visually estimated MRI-informed (cognitive fusion) techniqueTo 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.
Research Team
Badar M Mian, MD
Principal Investigator
Albany Medical College
Eligibility Criteria
Men who may have prostate cancer, with suspicious lesions seen on MRI scans and PSA levels at or below 20 ng/mL. They should not have had a prostate biopsy in the last three years and are about to undergo their first one.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo MRI-targeted prostate biopsy using either software-based fusion or cognitive fusion technique
Follow-up
Participants are monitored for detection rates of clinically significant prostate cancer
Treatment Details
Interventions
- Cognitive fusion prostate biopsy
- Software fusion prostate biopsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albany Medical College
Lead Sponsor