Plasma and Urine Biomarkers in Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898833
First received: May 9, 2009
Last updated: July 15, 2013
Last verified: July 2013
  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
Official Title: Laboratory Studies in Hormone Refractory Prostate Cancer - A Companion Study to CALGB 9480

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Correlation of plasma and urine vascular endothelial growth factor (VEGF) levels with survival duration [ Designated as safety issue: No ]
  • Plasma chromogranin A (CgA) and plasma interleukin-6 (IL-6) levels as predictors of survival duration [ Designated as safety issue: No ]
  • Plasma human Kallikrein 2 (hK2) levels as a prognostic factor for overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prognostic significance of plasma and urine VEGF levels, plasma CgA levels, plasma IL-6 levels, and plasma hK2 levels in relation to overall survival [ Designated as safety issue: No ]
  • Correlation of plasma VEGF levels with urine VEGF levels [ Designated as safety issue: No ]
  • Correlation of plasma CgA levels with previously measured serum prostate-specific antigen (PSA) and plasma VEGF levels [ Designated as safety issue: No ]
  • Predictive value of hK2 [ Designated as safety issue: No ]
  • Correlation of plasma hK2 levels with PSA levels [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2003
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.

PROJECTED ACCRUAL: A total of 225 patient samples will be collected for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced hormone-refractory adenocarcinoma of the prostate
  • Previously enrolled on CALGB-9480

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  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

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Philip Kantoff, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00898833     History of Changes
Other Study ID Numbers: CDR0000321397, CALGB-150201
Study First Received: May 9, 2009
Last Updated: July 15, 2013
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on July 26, 2014