NCT01967862

Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer

F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	computed tomography	Undergo CT
PROCEDURE	bone scan	Undergo bone scan
PROCEDURE	3-Tesla magnetic resonance imaging	Undergo axial MRI
PROCEDURE	diffusion-weighted magnetic resonance imaging	Undergo WB MRI
RADIATION	fluorine F 18 sodium fluoride	Undergo fluorine F 18 sodium fluoride PET/CT
PROCEDURE	computed tomography	Undergo fluorine F 18 sodium fluoride PET/CT
PROCEDURE	positron emission tomography	Undergo fluorine F 18 sodium fluoride PET/CT
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-12-01
• Primary completion: 2018-09-17
• Completion: 2018-09-17
• First posted: 2013-10-23
• Last updated: 2020-09-17
• Results posted: 2020-09-17

Locations

2 sites across 1 country: United States