Clinical trial NCT00898833: Plasma and Urine Samples From Patients With Hormone-Refractory Prostate Cancer Enrolled on Clinical Trials CALGB-9480 or CALGB-9583
Official title: Laboratory Studies in Hormone Refractory Prostate Cancer - A Companion Study to CALGB 9480 and 9583
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 868
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hormone refractory prostate cancer enrolled on CALGB-9480 or 9583

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.

Eligibility criteria: * Registration to CALGB 9480 or 9583
* Samples collected and shipped appropriately
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required

Primary outcomes:
measure: Confirmation of plasma VEGF levels inversely correlate with survival time
timeFrame: Up to 3 years
measure: Confirmation of urine VEGF levels inversely correlate with survival time
timeFrame: Up to 3 years
measure: CgA levels in predicting survival time
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary Ellen Taplin, MD
role: STUDY_CHAIR
References: