Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone

Study Overview
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Brief Summary
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RATIONALE: Imaging procedures, such as PET scan, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying carbon-11 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.

Detailed Description
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OBJECTIVES: Primary Correlate pre-treatment and 3-month post-treatment carbon-11 (^11C) acetate and fludeoxyglucose F 18 positron emission tomography (^18F-FDG PET) images with changes in clinical response measures in patients with bone-dominant metastatic prostate cancer. Secondary Compare ^11C acetate and ^18F-FDG PET scanning results with bone scintigraphy in these patients to determine which best predicts clinical response. Correlate changes in ^11C acetate and ^18F-FDG PET with changes in prostate-specific antigen level. Correlate changes in ^11C acetate and ^18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales). Correlate ^11C acetate and ^18F-FDG PET scan response with clinical time to progression. Determine if PET scan response can predict duration of progression-free survival. OUTLINE: This is a pilot study. Patients are stratified according to hormone response (sensitive [stratum 1] vs refractory [stratum 2]). Patients undergo carbon-11 acetate and fludeoxyglucose F 18 positron emission tomography imaging prior to and 3 months after initiation of either androgen-deprivation therapy (stratum 1) or docetaxel (stratum 2). Pain and quality of life are assessed at baseline and at 3 months. Patients are followed every 3 months for up to 5 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Official Title
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Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response

Conditions
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Metastatic Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: antiandrogen therapy
* Drug: docetaxel
* Diagnostic Test: C-11 acetate PET scan
* Diagnostic Test: F-18 FDG PET scan
* Diagnostic Test: Tc-99m bone scan
* Diagnostic Test: CT scan of the chest, abdomen and pelvis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of prostate cancer, meeting 1 of the following criteria: Metastatic hormone-sensitive disease prior to initiation of first-line androgen-deprivation therapy and meets the following criteria: Histologic confirmation of original diagnosis Hormone-sensitive is defined as progressive disease in the absence of androgen-deprivation therapy Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray Metastatic hormone-refractory disease prior to initiation of a first-line chemotherapy regimen that includes docetaxel and meets the following criteria: Histologic confirmation of original diagnosis Hormone-refractory is defined as development or advancement of metastatic disease with castrate testosterone levels (total testosterone < 20 ng/dL) Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray Must have castrate testosterone levels (< 20 ng/dL) from orchiectomy or undergoing maintenance with a luteinizing hormone-releasing hormone agonist Outside the window of a potential antiandrogen withdrawal response (either decline in prostate-specific antigen or objective response by imaging) PATIENT CHARACTERISTICS: Life expectancy > 12 weeks No serious underlying medical condition that would otherwise impair the patient's ability to receive treatment and undergo imaging studies No condition that would alter the patient's mental status, prohibiting the basic understanding and/or authorization of informed consent Able to lie still for the imaging Weight ≤ 300 lbs PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 6 weeks since prior bicalutamide or nilutamide At least 4 weeks since prior flutamide, ketoconazole, diethylstilbestrol, or estradiol More than 4 weeks since prior bisphosphonate therapy More than 4 weeks since prior radiotherapy to the bone More than 4 weeks since prior radiopharmaceutical treatment to the bone No concurrent radiotherapy

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antiandrogen therapy|nan|
|Drug: docetaxel|nan|
|Diagnostic Test: C-11 acetate PET scan|nan|
|Diagnostic Test: F-18 FDG PET scan|nan|
|Diagnostic Test: Tc-99m bone scan|nan|
|Diagnostic Test: CT scan of the chest, abdomen and pelvis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of pre-treatment and 3-month post-treatment carbon-11 (11C) acetate and fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) images with changes in clinical response measures |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of 11C acetate and 18F-FDG PET scanning results with bone scintigraphy to determine which best predicts clinical response |  |  | 
| Correlation of changes in 11C acetate and 18F-FDG PET with changes in prostate-specific antigen level |  |  | 
| Correlation of changes in 11C acetate and 18F-FDG PET with clinical symptom parameters (pain scale scores and analgesic usage scales) |  |  | 
| Correlation of changes in 11C acetate and 18F-FDG PET with clinical time to progression |  |  | 
| PET scan response as a predictor of duration of progression-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer, bone metastases