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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Software fusion prostate biopsy
Procedure/SurgerySoftware fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).
Cognitive fusion prostate biopsy
Procedure/SurgeryCognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and/or measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).
Treatment groups
1,306 Participants
are divided into 2 treatment groupsGroup A: Software fusion biopsyActive comparator 1 intervention
Group B: Cognitive fusion biopyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of clinically significant prostate cancer
Compare the overall detection of clinically significant prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame
1 yearSecondary outcomes
1
Detection of clinically significant prostate cancer in the targeted cores, systematic biopsy cores, and combined
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame
1 year2
Detection of clinically significant prostate cancer based on lesion size (< 0.5 cm; 0.5 cm to 1 cm; > 1.1 cm etc)
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame
1 year3
Detection of clinically significant prostate cancer at various lesion location (anterior, posterior, apex, base)
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame
1 year4
Detection rate of overall prostate cancer of any grade
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov