Status:
COMPLETED
Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
18-120 years
Brief Summary
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 acetat...
Detailed Description
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 clinic...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00392938
Start Date
December 1 2005
Last Update
March 13 2017
Active Locations (2)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
2
University of Washington School of Medicine
Seattle, Washington, United States, 98195