C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
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.
Procedure: needle biopsy
Drug: PET-CT scans supplemented with 11C-Choline tracer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate|
- Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.
|Study Start Date:||August 2008|
|Study Completion Date:||August 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
Procedure: needle biopsy
Biopsy of positive findings found on CT scanDrug: PET-CT scans supplemented with 11C-Choline tracer
Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804245
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Pradeep Garg, PhD||Wake Forest University Health Sciences|