NCT Number: NCT00392938
Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
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.
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Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
Male
Study type
Observational
Primary location
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
docetaxel
DrugC-11 acetate PET scan
Diagnostic TestF-18 FDG PET scan
Diagnostic TestTc-99m bone scan
Diagnostic TestCT scan of the chest, abdomen and pelvis
Diagnostic TestPrimary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Washington
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
Important dates
- Study start
- 2005
- Primary completion
- 2010
- First posted
- Oct 26, 2006
- Registry last updated
- Mar 13, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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