The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to
      establish our ability to reproduce results from the literature using FCH-PET/CT as a
      diagnostic and decision making tool in the management in two predefined groups of prostate
      cancer patients, specifically, biochemical recurrence and high risk staging. The primary
      endpoints of the study are the incidence of adverse events (AE) in the study population up to
      24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a
      per-patient and per-lesion basis.
    

Detailed description: 
      Background Prostate cancer is the second leading cause of cancer death in North American men
      older than 50 years. Positron emission tomography / computer tomography (PET/CT) is a nuclear
      medicine procedure based on the measurement of positron emission from radiolabeled tracer
      molecules. A common radiotracer in use today is 18F-fluoromethylcholine (aka fluorocholine or
      FCH) which is a radiolabeled choline derivative. Imaging with FCH-PET/CT can be used to
      characterize and localize prostate cancer in vivo. There is extensive data in the literature
      showing the value of FCH-PET/CT imaging in accurately staging and restaging prostate cancer.
      FCH-PET/CT is standard of care in many European countries.

      Study Objectives The objectives of this study are to confirm the safety and efficacy of
      FCH-PET/CT and to establish our ability to reproduce results from the literature using
      FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined
      groups of prostate cancer patients, specifically, biochemical recurrence and high risk
      staging. The primary endpoints of the study are the incidence of adverse events (AE) in the
      study population up to 24 hours following the scan, and the sensitivity and specificity of
      FCH-PET/CT vs CT on a per-patient and per-lesion basis.

      Study Design This will be a multi-center open label study in which one (1) FCH-PET/CT will be
      performed on study participants. A PET/CT scan takes 2-3 hours.

      Safety FCH-PET/CT exhibits favorable dosimetry, delivering organ doses that are comparable to
      or lower than those delivered by 18F-FDG. The safety of FCH is not disputed and we expect the
      number of adverse events in our study to be zero.

      Sample Size and Recruitment Target enrollment is 1500 patients. This will be sufficient to
      detect AE with a prevalence of 0.3% with 99% confidence. For efficacy endpoints,
      approximately 500 subjects would provide 90% power at the alpha=0.05 one-sided level of
      significance that the specificity and sensitivity will be superior to the specificity and
      sensitivity under the null hypothesis. Patients will be recruited by urologists in the
      clinical setting. Initial contact and consent will be by the department of urology.
    

Intervention name(s): 18F-Fluoromethylcholine (18F-FCH)
Intervention type(s): Drug
Intervention description(s): FCH PET/CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic