Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
Recruiting · NCT06517901 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive fusion prostate biopsySoftware fusion prostate biopsy
What this trial 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. 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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed across 3 US states.
- Lahey Clinic, Inc - Burlington, Massachusetts, United States
- Albany Medical Center - Albany, New York, United States
- Pennsylvania State University - Hershey, Pennsylvania, United States
- Manitoba Prostate Centre, CancerCare Manitoba - Winnipeg, Manitoba, Canada