Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Time to disease progression in bone metastasis identify by WB-MRI
Study Overview
Brief Summary
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.
Detailed Description
This is an observational study and will not influence the choice of treatment. The treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. This may include hormonal therapy or chemotherapy or therapy with radium-223. In addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. The duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician.
The use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. All other supportive or palliative treatments are permitted.
All patients will undergo imaging assessments as follows:
- At baseline, CT, BS (99mTc-MDP) and Whole Body-Magnetic Resonance Imaging (WB-MRI) will be performed.
- Follow-up imaging will be CT, BS and WB-MRI performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192.
Additional patient assessments to be performed include:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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,
- •Provision of written informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Time to disease progression in bone metastasis identify by WB-MRI
Time Frame: 192 weeks
the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS
Secondary Outcomes
No secondary outcomes reported