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

• Uptake of fluorine F 18 sodium fluoride on PET/CT scan [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  Determine if increased uptake of 18F-fluoride on PET/CT scan is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.
• Incidence of focal MRI abnormality [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.

This clinical trial is studying whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

PRIMARY OBJECTIVES:

I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.

II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.

OUTLINE:

Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.

• Bone Metastases
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

• Procedure: magnetic resonance imaging
  Undergo whole-body MRI
  Other Names:

  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
• Radiation: fluorine F 18 sodium fluoride
  Undergo fluorine F 18 sodium fluoride PET/CT scan
  Other Names:

  • 18 F-NaF
  • F-18 NaF
• Radiation: technetium Tc 99m methylene diphosphonate
  Undergo technetium Tc 99m methylene diphosphonate bone scan
  Other Names:

  • 99mTc-MDP
  • TechneScan MDP
  • technetium Tc 99m medronate

Inclusion Criteria:

• Histologically confirmed primary prostate cancer
• At high risk for bone metastases based on rising PSA levels despite androgen-deprivation therapy, PSA > 10 ng/mL, and/or PSA doubling time of ≤ 10 months
• ECOG performance status 0-1

• No uncontrolled concurrent illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would limit compliance with study requirements
• No known contraindications to MRI such as presence of MRI-incompatible devices (e.g., pacemakers and certain aneurysm clips), severe claustrophobia, or any other condition that would preclude proximity to a strong magnetic field
• No patients who are unable to tolerate or who have a life-threatening allergy to technetium Tc 99m methylene diphosphonate or fluorine F 18 sodium fluoride

• At least 7 days since prior and no concurrent other investigational therapeutic agents

  • No other investigational agents for > 7 days after completion of study treatment