NCT00392938CompletedNot Applicable
Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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 acetate and fludeoxyglucose F 18 PET scan of the bone in patients with metastatic prostate cancer that has spread to the bone.
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary 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
Investigators
Evan Y. Yu, MD
Principal Investigator
University of Washington
Study Sites (2)
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