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Clinical Trials/NCT00898833
NCT00898833
Terminated
N/A

Laboratory Studies in Hormone Refractory Prostate Cancer - A Companion Study to CALGB 9480 and 9583

Alliance for Clinical Trials in Oncology1 site in 1 country868 target enrollmentJuly 2003
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Alliance for Clinical Trials in Oncology
Enrollment
868
Locations
1
Primary Endpoint
Confirmation of urine VEGF levels inversely correlate with survival time
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is measuring plasma and urine biomarkers in patients with advanced prostate cancer that did not respond to hormone therapy.

Detailed Description

OBJECTIVES: Primary * Correlate plasma and urine vascular endothelial growth factor (VEGF) levels with survival duration in patients with advanced hormone-refractory adenocarcinoma of the prostate previously enrolled on CALGB-9480. * Determine whether plasma chromogranin A (CgA) and plasma interleukin-6 (IL-6) levels predict survival duration in these patients. * Determine whether plasma human Kallikrein 2 (hK2) levels are prognostic for overall survival of these patients. Secondary * Determine the prognostic significance of plasma and urine VEGF levels, plasma CgA levels, plasma IL-6 levels, and plasma hK2 levels in relation to overall survival of these patients. * Correlate plasma VEGF levels with urine VEGF levels in these patients. * Correlate plasma CgA levels with previously measured serum prostate-specific antigen (PSA) and plasma VEGF levels in these patients. * Correlate plasma hK2 levels with PSA changes after treatment with suramin to determine if hK2 may have predictive value, independent or additive to measures of disease response in these patients. * Correlate plasma hK2 levels with PSA levels in these patients. OUTLINE: Plasma from patients is collected for measurement of the following biomarkers: vascular endothelial growth factor (VEGF), chromogranin A, interleukin-6, and human Kallikrein 2. Urine is collected for VEGF measurement.

Registry
clinicaltrials.gov
Start Date
July 2003
End Date
June 2016
Last Updated
8 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Confirmation of urine VEGF levels inversely correlate with survival time

Time Frame: Up to 3 years

Confirmation of plasma VEGF levels inversely correlate with survival time

Time Frame: Up to 3 years

CgA levels in predicting survival time

Time Frame: Up to 3 years

Study Sites (1)

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