Hormone-Resistant Prostate Cancer, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma
Conditions
Brief summary
This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.
Detailed description
PRIMARY OBJECTIVES: I. Estimate the performance of simultaneous NaF/FDG PET/MRI for the prediction of treatment response in patients with metastatic castrate resistant prostate cancer (mCRPC). II. Estimate the performance of simultaneous NaF/FDG PET/MRI for detection of extra-skeletal disease progression during treatment in mCRPC patients. OUTLINE: Patients receive 18F NaF and 18F FDG intravenously (IV) over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223. After completion of study, patients are followed up for up to 12 months.
Interventions
Given IV
PROCEDUREMagnetic Resonance Imaging
Undergo PET/MRI
PROCEDUREPositron Emission Tomography
Undergo PET/MRI
Undergo contrast-enhanced MRI
DRUGFludeoxyglucose F-18
Given IV
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provides written informed consent * Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride) * Able to remain still for duration of the imaging procedure (about one hour)
Exclusion criteria
* Metallic implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size | 24 weeks | Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model. |
| Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value | 12 weeks | — |
| Percent reduction at 12 weeks in MRI lesion size (per lesion analysis) | 12 weeks | — |
| Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity | 24 weeks | Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model. |
| Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis) | 24 weeks | Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size. The logistic regression will include an adjustment for clustering. The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| True status (true positive or false positive) of such lesions after 12 months of follow-up, based on all information except NaF/FDG PET/MRI (per lesion analysis) | 12 months | The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals. |
| Presence of new or regrowing extra-skeletal disease at 12 and/or 24 weeks on NaF/FDG PET/MRI that is not present on corresponding standard-of-care 99mTc-MDP bone scintigraphy and CT (per lesion analysis) | Up to 24 weeks | — |
Countries
United States
Outcome results
None listed