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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| UWCC-6129 | |||
| UWCC-06-0500-H/A | |||
| FHCRC-6129 | |||
| CDR0000480347 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiandrogen therapy | Drug | |||
| docetaxel | Drug | |||
| 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 | Diagnostic Test |
| 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 |
| 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 |
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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:
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Y. Yu, MD | Seattle Cancer Care Alliance | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States | ||
| University of Washington School of Medicine |
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| 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 |
| Seattle |
| Washington |
| 98195 |
| United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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