Prostate Cancer Screening with short, unenhanced Magnetic Resonance Imaging
- Conditions
- bpMRI of the prostate
- Registration Number
- DRKS00031035
- Lead Sponsor
- Charité Universitätsmedizin Berlin, Klinik für Radiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 900
1. participants must be able to undergo all procedures listed in the protocol
2. Estimated life expectancy of 10 years or more.
3. sufficient understanding of the German language to understand written and verbal information about the study and the consent process
4. consent to participate in the study
1. previous prostate biopsy or prostate MRI within the last 6 months prior to study inclusion.
2. evidence of urinary tract infection or history of acute prostatitis within the last 6 months.
3. history/treatment of prostate cancer (surgery for benign prostatic hyperplasia is not an exclusion criterion).
4. any potential contraindication to MRI.
5. dementia or altered mental status that may interfere with understanding or giving consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of men with positive bpMRI (defined as a PI-RADS score of 4-5) or positive PSA test (defined as PSA = 4 ng/mL).
- Secondary Outcome Measures
Name Time Method umber of clinically significant and clinically non-significant prostate cancers detected if each screening test (bpMRI or PSA test) had been used exclusively.