Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00392938|
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : March 13, 2017
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.
|Condition or disease||Intervention/treatment|
|Metastatic Cancer Prostate Cancer||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|
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||May 2010|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392938
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|University of Washington School of Medicine|
|Seattle, Washington, United States, 98195|
|Study Chair:||Evan Y. Yu, MD||Seattle Cancer Care Alliance|