18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging
      patients with high risk prostate cancer.

      Study Hypothesis:

      FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as
      compared to conventional imaging.
    

Detailed description: 
      Up to 60% of patients treated with radical prostatectomy or external beam radiotherapy for
      prostate cancer will have biochemical failure at 5 years. This may be due to several reasons,
      including presence of sub-clinical metastases at time of local therapy.

      Currently, patients with high risk prostate cancer are staged by MRI of the prostate (to
      assess local extent of disease), CT of the abdomen(to detect spread to lymph nodes) and bone
      scan (to assess for spread to bones). However, these standard imaging exams do not always
      identify all sites of disease. Recent research has suggested that performing positron
      emission tomography (PET) scanning with a tracer called fluorocholine (FCH) improves
      identification of lymph node and bone metastases in prostate cancer, resulting in more
      accurate diagnosis.

      The main goal of this study is to find out whether staging high risk prostate cancer patients
      with FCH PET-CT and MRI of the whole body will improve detection of primary tumors and
      metastases compared to current standard imaging exams. Improved staging of patients with
      prostate cancer may impact patient care as it will help to select more appropriate therapy.

      In this study, participants will undergo either combined PET/MRI or PET-CT and MRI after
      standard evaluations. The accuracy of each staging approach (standard vs. PET and MRI) will
      be evaluated. In addition, we will incorporate novel methods for data interpretation by
      creating imaging maps combining data from PET and MRI (termed "Multiparametric maps"). The
      goal of this novel approach is to find out whether mapping 2 or more characteristics of a
      tumor at the same time will improve tumor detection and accuracy of diagnosis.

      About 40 men from the Princess Margaret Hospital will take part in this study. The study
      should take about 2 years to complete enrollment and the results should be known within 36
      months of completion of enrollment.
    

Intervention name(s): Fluorocholine (18F-FCH) Injection; PET scan; Whole body MRI
Intervention type(s): Drug; Radiation; Radiation
Intervention description(s): Before the PET-CT scan, the tracer (fluorocholine/FCH) will be injected into a vein in your arm just before the scan. This is the agent we are investigating in this study (not part of the standard procedure); A whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI; A whole body MRI scan will be performed. This may be integrated with PET scan or performed separately.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fluorocholine (FCH); Positron emission tomography (PET); Magnetic resonance imaging (MRI)