Study Title: Multi-parametric Ultrasound Imaging to Detect and Rule-out Clinically Significant Prostate Cancer
Short Title: CADMUS
This study compares a diagnostic strategy for prostate cancer using a newer type of ultrasound scanning with the existing one (magnetic resonance imaging (MRI)). We will look at men who have already had one prostate biopsy and are referred for risk stratification. At present MRI scanning is used to identify areas of the prostate which may contain cancer and would warrant further investigation with biopsy. MRI however is a relatively expensive test and is not suitable for all men such as those with metal implants, poor kidney function and claustrophobia. If ultrasound scanning, which is perhaps half the cost of MRI, could be substituted the economic gains might be considerable. Ultrasound could also be performed in the outpatient setting by the urologist, removing a visit to hospital. The study will be conducted at University College Hospital, and six other sites. Men in this study will all undergo a multi-parametric MRI scan (the normal diagnostic pathway) as well as a multi-parametric ultrasound scan in two outpatient visits. Any abnormalities on these two scans considered suspicious for cancer will be biopsied under local anaesthetic and optional sedation. The biopsy results for abnormalities detected by ultrasound will be compared with the biopsy results for those abnormalities seen on MRI in order to answer our primary research question. There are 7 UK sites and this trial will register 400 patients, out of which 275 patients will be randomised.
Sponsor: University College London
Funder: Prostate Cancer UK and the Moulton Foundation
ClinicalTrials.gov Identifier: NCT02712684