C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: needle biopsy
* Drug: PET-CT scans supplemented with 11C-Choline tracer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiolabeled choline tracer scans<br>PET-CT scans supplemented with Choline 11 tracer | Procedure: needle biopsy<br>* Biopsy of positive findings found on CT scan<br>Drug: PET-CT scans supplemented with 11C-Choline tracer<br>* Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans | To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease. | Approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer