C61
Conditions
Interventions
Group 1: For men with suspected prostate cancer and an indication for an MRI, additional MRI sequences are added to the standard protocol.
Sponsors
Virdx Deutschland GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients are scheduled for an mpMRI examination due to suspected prostate carcinoma
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
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 receiver operating characteristic (ROC) curve of the models in comparison. The primary endpoints are determined after the calculation of the models following the MRI examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison with PI-RADS classification and potential biopsy results. | — |
Countries
Germany
Contacts
Public ContactMichael Ho
ARISTRA GmbH Praxis Standort Münster
Outcome results
None listed