Plasma and Urine Biomarkers in Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898833
First received: May 9, 2009
Last updated: March 29, 2011
Last verified: March 2011
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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 National Cancer Institute (NCI):
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 ]
| Estimated Enrollment: | 225 |
| Study Start Date: | July 2003 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898833
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
Cancer and Leukemia Group B
Investigators
| Study Chair: | Philip Kantoff, MD | Dana-Farber Cancer Institute |
More Information
Additional 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: | March 29, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 June 18, 2013