C61
Conditions
Interventions
Group 1: Patients with suspected prostate cancer will be recruited during routine clinical care at the participating urology departments. After providing written informed consent, all participants wil
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Consecutive patients with suspected prostate cancer scheduled for prostate mpMRI and potential biopsy according to current guidelines. Patients will be recruited in the department of urology at the different study sites.
Exclusion criteria
Exclusion criteria: Non-interpretable examinations (PI-QUAL 1). Patients who have undergone surgery or radiotherapy for prostate cancer. Discrepancies and incorrect MR report (filtered out by expert). No signed informed consent. Contraindication for MRI or biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the diagnosis of clinically significant prostate cancer (csPCa) (ISUP Grade Group = 2) based on a PI-RADS score = 3, using the histopathological results of the subsequent biopsy as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the number of clinically significant prostate cancers detected in comparison with the PI-RADS classification. | — |
Countries
Germany
Contacts
Public ContactMatthias Boschheidgen
Universitätsklinikum Düsseldorf
Outcome results
None listed