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Clinical Trials/NCT06321679
NCT06321679
Recruiting
Not Applicable

Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study

European Institute of Oncology1 site in 1 country40 target enrollmentJuly 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Castration-resistant Prostate Cancer
Sponsor
European Institute of Oncology
Enrollment
40
Locations
1
Primary Endpoint
Time to disease progression in bone metastasis identify by WB-MRI
Status
Recruiting
Last Updated
2 years ago

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: * questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities. * clinical and physical examinations according to routine clinical practice. The radiologist reporting the WB-MRI will be blinded to the results of the CT and BS. The radiologist reporting the CT and the nuclear medicine physician reporting the BS will likewise be blinded to the results of the WB-MRI. Neither treating clinicians nor patients will be blinded at any point.

Registry
clinicaltrials.gov
Start Date
July 3, 2020
End Date
December 31, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
European Institute of Oncology
Responsible Party
Sponsor

Eligibility Criteria

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

Study Sites (1)

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