FUTURE trial; A multicentre randomised controlled trial on three target biopsy techniques in the diagnostic work-up of prostate cancer
Recruiting
- Conditions
- Prostate cancer
- Registration Number
- NL-OMON28778
- Lead Sponsor
- St Antonius Hospital NieuwegeinCanisius Wilhelmina Hospital NijmegenRadboud University Medical Center NijmegenUniversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 674
Inclusion Criteria
Subjects (at least 18 years old and mentally competent) with at least one negative TRUS guided biopsy session within the last 2 years (with a minimum of 8 biopsy cores taken from the peripheral zone) but a persistent clinical suspicion on prostate cancer based on a PSA value of >4.0 ng/ml and/or suspicious rectal examination are candidates for recruitment.
Exclusion Criteria
Exclusion criteria are prior diagnosed or treated prostate cancer, a urinary tract infection, unwillingness or inability to undergo MR imaging and/or target biopsy session, or follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the clinical role (i.e. detection of significant prostate cancer) of MRI/TRUS fusion target biopsy on prostate cancer detection, compared with in-bore MRI target biopsy and cognitive TRUS target biopsy, in men with a persistent clinical suspicion on prostate cancer and at least one negative TRUS guided biopsy session.
- Secondary Outcome Measures
Name Time Method To perform histopathological validation of mpMRI imaging and PI-RADS classification system using target biopsy cores. <br /><br><br /><br>To perform histopathological validation of Computer Aided Diagnosis algorithms (Watson Elementary) within the fusion groups of subjects undergoing prostatectomy following biopsy procedures using prostatectomy specimens. <br /><br><br /><br>To analyse cost-effectiveness of all three target biopsy strategies. <br /><br><br /><br>To evaluate the follow-up amongst subjects with a negative mpMRI and/or negative target biopsy outcome <br>