Expired Study
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Winston-Salem, North Carolina 27157


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.

Study summary:

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.


Inclusion Criteria: - 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 Exclusion Criteria: - 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



Primary Contact:

Study Chair
Pradeep Garg, PhD
Wake Forest University Health Sciences

Backup Contact:


Location Contact:

Winston-Salem, North Carolina 27157
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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