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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898833
First received: May 9, 2009
Last updated: June 30, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Laboratory Studies in Hormone Refractory Prostate Cancer - A Companion Study to CALGB 9480 and 9583

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Confirmation of plasma VEGF levels inversely correlate with survival time [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Confirmation of urine VEGF levels inversely correlate with survival time [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • CgA levels in predicting survival time [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Plasma, serum, urine

Estimated Enrollment: 868
Study Start Date: July 2003
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hormone refractory prostate cancer enrolled on CALGB-9480 or 9583
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898833

Contacts
Contact: Mary Ellen Taplin, MD (617) 632-3237

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute    877-275-7724      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Mary Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898833     History of Changes
Other Study ID Numbers: CALGB-150201  CDR0000321397 
Study First Received: May 9, 2009
Last Updated: June 30, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016