About this trial
This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.
This is a monocentric, prospective observational study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological diagnosis of castration-resistant prostate cancer,
Single or multiple bone metastases,
Life expectancy of over 6 months,
No current active malignancy other than prostate cancer,
Disqualifiers
Absolute contraindication to WB-MRI, CT or BS,
Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),
Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.
Trial population
The estimated rate of recruitment to the study 6-7 patients a month, thus it is expected that patient accrual will be completed within 7 months. Based on recent treatment patterns, the expected distribution of treatments is: * Hormonal treatments * Enzalutamide: 14 patients * Abiraterone: 8 patients * Chemotherapy * Docetaxel: 11 patients * Cabazitaxel: 5 patients * Radiopharmaceutical drug - Radium-223: 2 patients
Trial design
Cohort
Prospective
Treatments tested in this trial
Imaging evaluation
Procedure/Surgeryeach patient will undergo imaging with CT, BS and WB-MRI at each study timepoint
Treatment groups
Trial outcomes
Primary outcomes
Time to disease progression in bone metastasis identify by WB-MRI
the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS
Sponsors and contacts
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