Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282906
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2006-01-25
Brief Title:
FDG Positron Emission Tomography and Computed Tomography PET-CT in Metastatic Prostate Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
F-18-Fluorodeoxyglucose FDG Positron Emission Tomography and Computed Tomography PET-CT in Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This is an National Institute of Health NIH funded investigator-initiated single center prospective study to investigate the ability of the new dual-modality positron emission tomography and computed tomography PET-CT imaging systems in comparison to conventional imaging methods in assessing treatment response in men with metastatic prostate cancer The investigators will enroll two groups of men with stage IV metastatic prostate cancer each group will be comprised of 160 patients
Group I men with newly diagnosed hormone-responsive measurable metastatic disease who will be treated with androgen-ablation therapy
Group II men with newly-developed hormone-refractory measurable metastatic disease who will be treated with chemotherapy and or other therapies for hormone refractory disease
To be eligible men in either group must have rising serum prostate specific antigen PSA level - defined as at least 2 consecutive rises in PSA documented over a reference value 1st measure within 28 days prior to recruitment The first rising PSA 2nd measure should be taken at least 14 days after the reference value A confirmatory PSA measure 3rd measure obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd measure Additionally patients must have a serum PSA concentration of at least 2 ngmL in addition to increasing PSA to be eligible Patients will be followed with the PET-CT at 4 8 and 12 months after the initiation of androgen ablation therapy Group I or chemotherapy Group II
Group I men with newly diagnosed hormone-responsive measurable metastatic disease who will be treated with androgen-ablation therapy
Group II men with newly-developed hormone-refractory measurable metastatic disease who will be treated with chemotherapy and or other therapies for hormone refractory disease
To be eligible men in either group must have rising serum prostate specific antigen PSA level - defined as at least 2 consecutive rises in PSA documented over a reference value 1st measure within 28 days prior to recruitment The first rising PSA 2nd measure should be taken at least 14 days after the reference value A confirmatory PSA measure 3rd measure obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd measure Additionally patients must have a serum PSA concentration of at least 2 ngmL in addition to increasing PSA to be eligible Patients will be followed with the PET-CT at 4 8 and 12 months after the initiation of androgen ablation therapy Group I or chemotherapy Group II
Detailed Description:
Our long-range objective is to obtain pilot data to investigate the ability of the new dual-modality positron emission tomography and computed tomography PET-CT imaging systems for assessing treatment response in patients with metastatic prostate cancer in comparison to conventional imaging PET-CT is not employed here for staging all men in this study will have stage IV metastatic prostate cancer We believe that the combined anatomic and in-vivo metabolic imaging information provided by PET-CT allows accurate objective assessment of such critical clinical issues as early prediction and evaluation of response or resistance to various therapeutic interventions including the novel chemotherapy regimen as well as the prediction of key clinical outcomes such as time to hormone-refractoriness and survival Our intermediate-range objective is therefore to investigate the diagnostic and prognostic utility of PET-CT with the most commonly available PET tracer F-18-fluorodeoxyglucose FDG in metastatic prostate cancer We plan to correlate the treatment-induced changes of glucose metabolism in metastatic prostate cancer lesions to the changes in various conventional clinical laboratory and diagnostic imaging parameters such as serum prostate-specific antigen level lesion size time to androgen independence and survival This objective is motivated by our preliminary basic science and clinical data as well as the published reports of other investigators demonstrating the pragmatic potential diagnostic and prognostic utility of FDG PET-CT in men with metastatic prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None