bpMRI of the prostate
Conditions
Interventions
Group 1: Interventional arm: Investigation of the use of bpMRI as a screening examination for prostate cancer.
Sponsors
Charité Universitätsmedizin Berlin, Klinik für Radiologie
Eligibility
Sex/Gender
Male
Age
50 Years to 69 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of clinically significant and clinically non-significant prostate cancers detected if each screening test (bpMRI or PSA test) had been used exclusively. | — |
Countries
Germany
Contacts
Public ContactFederico Collettini
Charité Universitätsmedizin Berlin, Klinik für Radiologie
Outcome results
None listed