11C- and 18F-Choline PET/MR Imaging for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Carbon C 11 Choline; Fluorine F 18 Choline; Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Intervention description: Given intravenously (IV) prior to imaging; Given intravenously (IV) prior to imaging; Undergo whole-body PET/MR imaging
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline
      (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging
      works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer.
      Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose
      prostate cancer and find out how far the disease has spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: Patients must be >=18 years of age

          -  Diagnosis: Patients must have a diagnosis of prostate cancer by histologic
             verification and a hypoechoic lesion seen on ultrasound.

          -  Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer
             of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10)

          -  Karnofsky Performance Status >=70

          -  Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan

          -  Planned to undergo radical prostatectomy and extended pelvic lymph node dissection

          -  Adequate bone marrow and organ function defined as follows:

          -  Adequate bone marrow function:

          -  Leukocytes >= 3,000/microliter (mcL)

          -  Absolute Neutrophil Count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Adequate hepatic function:

          -  Total bilirubin - within normal institutional limits

          -  Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) <=
             2.5 X institutional upper limit of normal

          -  Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <= 2.5 X
             institutional upper limit of normal

          -  Adequate renal function:

          -  Creatinine - within normal institutional limits OR

          -  Creatinine clearance >= 60 mL/min/ 1.73m2 for patients with creatinine levels above
             institutional normal

          -  Ability to understand a written informed consent document, and the willingness to sign
             it

        Exclusion Criteria:

          -  Participation would significantly delay the scheduled standard of care therapy

          -  Karnofsky performance status of < 60

          -  Inadequate venous access

          -  Administered a radioisotope within 5 physical half lives prior to study enrollment

          -  Have a medical condition or other circumstances which, in the opinion of the
             investigator would significantly decrease the chances of obtaining reliable data,
             achieving the study objectives, or completing the study.