Met prostaat MRI Meer Mans
Recruiting
- Conditions
- Prostate cancer, molecular urine test, mri prostate, mri guided biopsy, prostate risc calculator, PSA, TRUS biopsyDutch: Prostaatkanker, moleculaire biomarker, prostaat risico calculator, MRI, MRI geleide biopsie, echo gelede transrectale biopsie, PSA
- Registration Number
- NL-OMON22730
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 660
Inclusion Criteria
• Men aged 50-75 years
• PSA ≥ 3.0 ng/ml
Exclusion Criteria
• Impossibility to obtain a valid informed consent
• History of previous prostate biopsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the additional value of mp-MRI and MRI-guided biopsy in men with an elevated PSA regarding the detection of both insignificant and significant cancer, and reducing biopsies.
- Secondary Outcome Measures
Name Time Method To determine the cost-effectiveness of such an additional mp-MRI-procedure compared to random TRUS-guided biopsy, which is standard of care”.<br><br /><br /><br>To determine the influence of both procedures on quality of life.<br><br /><br /><br>To determine the added value of the prostate risk calculator, Quattro urine test and mp-MRI.<br><br /><br /><br>To define the optimal PSA threshold as from 3 ng/ml for proceeding to performing prostate biopsies<br><br /><br /><br>To investigate the accuracy of the Gleason scores of positive biopsies in predicting the definite Gleason score of available radical prostatectomy specimens<br>