Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine in Prostate Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to better understand a new type of radiology test called positron emission tomography (PET) with carbon 11 methionine to determine which patients have a beneficial effect from anti-cancer therapy with the drug docetaxel.

Detailed Description
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In the week before the patients first dose of chemotherapy they will receive a C11 methionine PET scan which takes about 90 minutes. C11 methionine is a radioactively labeled amino acid that is given to the patient intravenously. Eighteen to twenty days after the patients first dose of docetaxel chemotherapy, they will have another C11 methionine PET scan which is identical to the first scan. At the end of three cycles of docetaxel chemotherapy (about 2 and 1/2 months on study) another C11 methionine PET scan will be done. The PET scans will show how well the tumor is taking up methionine.

Official Title
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An Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine (C11 MET) in Prostate Cancer, as Assessed by Positron Emission Tomography (PET)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: C11 Methionine PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic hormone-refractory prostate cancer patients who are planned to begin every 3-week docetaxel chemotherapy Progression after androgen deprivation therapy Serum testosterone < 50ng/ml 18 years of age or older Exclusion Criteria: Prior taxane therapy

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: C11 Methionine PET scan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the association between percent change in tumor standardized uptake value (SUV) after c11 methionine administration after one cycle of every three-week docetaxel-based chemotherapy and prostate-specific antigen (PSA) response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the relative value of the change in tumor SUV after C11 methionine administration after one cycle and 3 cycles of docetaxel with respect to PSA progression |  |  | 
| to explore optimal cutpoints and measures of SUV change for distinguishing responders from non-responders and progressors from non-progressors and |  |  | 
| to evaluate the relationship between the percent change is tumor SUV after C11 methionine administration with freedom from PSA progression in 6 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Hormone-refractory prostate cancer, PET scan, C11-methionine, positron emission tomography