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

August 7, 2017 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

868

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with hormone refractory prostate cancer enrolled on CALGB-9480 or 9583

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
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.
Other: laboratory biomarker analysis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mary Ellen Taplin, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-150201
  • CDR0000321397 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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