Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392938
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2006-10-25
Brief Title:
Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Positron Emission Tomography Imaging of Bone in Patients With Metastatic Prostate Cancer - A Pilot Study Evaluating Treatment Response
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Imaging procedures such as PET scan may help doctors predict a patients 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000480347 | REGISTRY | PDQ | httpsreporternihgovquickSearchP30CA015704 |
| UWCC-6129 | None | None | None |
| P30CA015704 | NIH | None | None |
| UWCC-06-0500-HA | None | None | None |
| FHCRC-6129 | None | None | None |