NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

Metastatic Prostate Carcinoma Clinical Trial

Official title:

Combined "One Stop Shop" NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02429804
• Other study ID #: PROS0063
• Secondary ID: NCI-2015-00553ep
• Status: Terminated
• Phase: Phase 1
• First received: April 17, 2015
• Last updated: May 24, 2017
• Start date: April 2015
• Est. completion date: May 15, 2017

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Hormone-Resistant Prostate Cancer
• Metastatic Malignant Neoplasm in the Bone
• Metastatic Prostate Carcinoma
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Prostatic Neoplasms

Intervention

Procedure:
• Contrast-enhanced Magnetic Resonance Imaging
Undergo contrast-enhanced MRI

Drug:
• Fludeoxyglucose F-18
Given IV
• Fluorine F 18 Sodium Fluoride
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo PET/MRI
• Positron Emission Tomography
Undergo PET/MRI

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity	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.	24 weeks
Primary	Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size	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.	24 weeks
Primary	Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis)	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.	24 weeks
Primary	Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value		12 weeks
Primary	Percent reduction at 12 weeks in MRI lesion size (per lesion analysis)		12 weeks
Secondary	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
Secondary	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)	The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals.	12 months