Plasma and Urine Samples From Patients With Hormone-Refractory Prostate Cancer Enrolled on Clinical Trials CALGB-9480 or CALGB-9583

Alliance for Clinical Trials in Oncology

Status: Terminated

Conditions: Prostate Cancer

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898833

CALGB-150201

CDR0000321397 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 868 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

868 participants in 1 patient group

Group 1

Description:

Previously collected plasma and urine samples are analyzed for VEGF via ELISA, plasma samples are analyzed for CgA and IL-6 via ELISA, hK2 via immunometric assay, plasma samples are analyzed for PSA via Tandem-R PSA kit, plasma samples are analyzed for TNF-alpha, sTNF-R1, and IL-8 via quantikine IL-8 immunoassay.

Treatment:

Other: laboratory biomarker analysis