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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Correlation of plasma and urine vascular endothelial growth factor (VEGF) levels with survival duration

Safety Issue:

No

Principal Investigator

Philip Kantoff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000321397

NCT ID:

NCT00898833

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263