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TerminatedNCT00898833Updated Aug 8, 2017

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

An observational study in Prostate Cancer, sponsored by Alliance for Clinical Trials in Oncology. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Alliance for Clinical Trials in Oncology · Observational

Why this study was terminated
The proposed work could not be completed.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
868
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's planned enrollment of 868 is above the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Browse Alliance for Clinical Trials in Oncology studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility 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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
868 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Confirmation of plasma VEGF levels inversely correlate with survival time

    Time frame: Up to 3 years

  2. Confirmation of urine VEGF levels inversely correlate with survival time

    Time frame: Up to 3 years

  3. CgA levels in predicting survival time

    Time frame: Up to 3 years

07

Study locations

1 site
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00898833
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jul 2003
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Aug 8, 2017

Study contacts

Mary Ellen Taplin, MD
study chair · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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