Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorEuropean Institute of Oncology

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Imaging evaluation

    Procedure/Surgery

    each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: WB-MRI1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
192 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.