C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in
      finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.

      PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding
      metastases in patients with newly diagnosed high-risk prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the sensitivity and specificity of PET-CT scan using C-11 choline in
           detecting bone and lymph node metastases in patients with newly diagnosed high-risk
           adenocarcinoma of the prostate.

      Secondary

        -  To perform semi-quantitative analysis of tracer uptake using standard uptake values and
           qualitative analysis using pure visual analysis.

        -  To develop an algorithm that includes the routine use of C-11 choline PET-CT scan for
           the staging of patients with prostate cancer at high risk of metastatic disease.

        -  To determine whether the presence of C-11 choline PET-CT scan positivity in these
           patients is predictive of outcomes, including biochemical relapse-free survival, time to
           development of clinically apparent metastases, time to local failure, and overall
           survival.

        -  To obtain tissue specimens from these patients for correlative studies and further
           evaluation.

        -  To obtain information regarding the feasibility and characteristics of C-11 choline
           PET-CT scan after androgen suppression.

      OUTLINE: Patients undergo CT scan of the abdomen and pelvis with IV contrast and a bone scan.
      Patients also undergo a C-11 choline PET-CT scan*. In the case of any positive scan, patients
      undergo a needle biopsy. If the biopsy is negative for metastatic disease or if the biopsy is
      positive for metastatic disease in a draining lymph node region, patients receive
      radiotherapy and hormonal (antiandrogen) therapy. If the biopsy is positive for metastatic
      disease at any other site, patients receive hormonal therapy alone.

      NOTE: *The first 10 patients enrolled on the study who have a positive PET-CT scan and
      positive biopsy undergo a second PET-CT scan at 6 months after the initial PET-CT scan.

      Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
    

Intervention name(s): needle biopsy; PET-CT scans supplemented with 11C-Choline tracer
Intervention type(s): Procedure; Drug
Intervention description(s): Biopsy of positive findings found on CT scan; Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer
Intervention MeSH terms: Choline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer