C61
Conditions
Interventions
Group 1: In men with planned radical prostatectomy (RPE), additional MRI sequences to the standard protocol are recorded and the prostate is processed histopathologically.
Sponsors
Virdx Deutschland GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with biopsy-proven prostate cancer for whom an RPE examination is planned
Exclusion criteria
Exclusion criteria: - Patients have a contraindication for an MRI examination - Patients have received prior radiation therapy to the prostate, hormone therapy, prior TUR-P or other prostate surgery - Patients have had a total hip replacement implanted - Patients lack willingness, ability and capacity to consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Comparison with histopathological tissue measurements. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary aim of the study is to compare biophysical models with regard to the accuracy of the diagnosis of prostate cancer. The primary endpoints are sensitivity, specificity and area under the curve (AUC) of the models in comparison. The primary endpoints are determined after the calculation of the models following the MRI examination and the histopathological workup. | — |
Countries
Germany
Contacts
Public ContactClaudia Kesch
Klinik und Poliklinik für Urologie
Outcome results
None listed