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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00898833

Enrollment

868

Registered

2009-05-12

Start date

2003-07-31

Completion date

2016-06-30

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

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.

Interventions

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Confirmation of plasma VEGF levels inversely correlate with survival time	Up to 3 years
Confirmation of urine VEGF levels inversely correlate with survival time	Up to 3 years
CgA levels in predicting survival time	Up to 3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026