C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: needle biopsyDrug: PET-CT scans supplemented with 11C-Choline tracer
- Registration Number
- NCT00804245
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
- Histologically confirmed adenocarcinoma of the prostate
- Prior negative prostate biopsy allowed
- High-risk disease, as defined by one of the following:
- PSA ≥ 20 ng/mL
- Gleason score ≥ 8
- Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
- Creatinine < 2.0 mg/dL
- Able to tolerate PET scan, CT scan, and bone scan
- Able to tolerate IV and oral contrast
- Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan
- Other cancer within the past 5 years (except for nonmelanoma skin cancer)
- No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description radiolabeled choline tracer scans needle biopsy PET-CT scans supplemented with Choline 11 tracer radiolabeled choline tracer scans PET-CT scans supplemented with 11C-Choline tracer PET-CT scans supplemented with Choline 11 tracer
- Primary Outcome Measures
Name Time Method Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans Approximately 1 year To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States