Overview

This trial is active, not recruiting.

Condition recurrent prostate cancer
Treatments computed tomography, bone scan, 3-tesla magnetic resonance imaging, diffusion-weighted magnetic resonance imaging, fluorine f 18 sodium fluoride, positron emission tomography, laboratory biomarker analysis
Phase phase 2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date December 2013
End date August 2017
Trial size 56 participants
Trial identifier NCT01967862, 13365, NCI-2013-01924

Summary

This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography tomography, computed
Undergo CT
bone scan
Undergo bone scan
3-tesla magnetic resonance imaging 3-Tesla MRI
Undergo axial MRI
diffusion-weighted magnetic resonance imaging diffusion-weighted MRI
Undergo WB MRI
fluorine f 18 sodium fluoride 18 F-NaF
Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography tomography, computed
Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography FDG-PET
Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Percent of patients with negative standard scans and positive on the newer scans
time frame: Up to 6 months

Secondary Outcomes

Measure
Percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done
time frame: Up to 6 months
Proportion of patients with biochemically recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan
time frame: Up to 52 weeks
Presence of metastatic disease detected using WB/axial MRI and/or fluorine F 18 sodium fluoride PET/CT
time frame: Up to 52 weeks
Ability of axial MRI to identify sites of disease
time frame: Up to 52 weeks
Ability of WB MRI to identify sites of disease
time frame: Up to 52 weeks
Relative contribution of fluorine F 18 sodium fluoride PET/CT
time frame: Up to 52 weeks
Relative contribution of MRI
time frame: Up to 52 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - History of prior radical prostatectomy for prostate cancer - Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy - Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan Exclusion Criteria: - Patients with known metastatic disease - PSA recurrence not verified by elevated PSA as discussed in the eligibility section - Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed

Additional Information

Official title F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer
Principal investigator Przemyslaw Twardowski
Description PRIMARY OBJECTIVES: I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan. SECONDARY OBJECTIVES: I. To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done. II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan. III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline. IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI. OUTLINE: Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan. After completion of study, patients are followed up at 4-6 months and periodically until week 52.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.
Location data was received from the National Cancer Institute and was last updated in August 2016.