Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorAlbany Medical College
About 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) 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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Software fusion prostate biopsy
- Cognitive fusion prostate biopsy
Treatment groups
1,306 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov