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Studying Stored Samples From Patients With Localized Prostate Cancer Treated on Clinical Trial NCI-00-C-0154

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535834
First Posted: September 26, 2007
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

RATIONALE: Studying samples of blood in the laboratory from patients before and after treatment may help doctors learn more about the effects of the treatment on cells.

PURPOSE: This clinical trial is studying samples collected from patients with localized prostate cancer who received treatment on clinical trial NCI-00-C-0154.


Condition Intervention
Prostate Cancer Procedure: diagnostic procedure Procedure: molecular diagnostic method Procedure: protein expression analysis

Study Type: Observational
Official Title: Data Analysis for 00-C-0154, A Randomized Phase II Study of a PSA-based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Immunologic response
  • Incidence of formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy by western blot and SEREX

Secondary Outcome Measures:
  • Cloning of any underlying tumor antigens discovered in this process

Estimated Enrollment: 48
Study Completion Date: March 2011
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy in prostate cancer patients previously enrolled on clinical trial NCI-00-C-0154.
  • Evaluate immunologic response.

Secondary

  • Clone the underlying tumor antigens discovered through SEREX.

OUTLINE: Samples previously collected on clinical trial NCI-00-C-0154 (whole blood, serum, and peripheral mononuclear blood cells) are analyzed for immunologic responses and evidence of formation of anti-tumor antibodies. Western blot is used to detect any evidence of vaccine-induced autoantibody responses. If there is an indication of response, SEREX is used to clone the underlying antigens.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of localized adenocarcinoma of the prostate
  • Received treatment on clinical trial NCI-00-C-0154

PATIENT CHARACTERISTICS:

  • Consented the use of their collected blood cells for future research while enrolled on NCI-00-C-0154

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535834


Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Gulley, MD, PhD National Cancer Institute (NCI)
  More Information

ClinicalTrials.gov Identifier: NCT00535834     History of Changes
Other Study ID Numbers: 999907214
07-C-N214
CDR0000565972
First Submitted: September 25, 2007
First Posted: September 26, 2007
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
stage I prostate cancer
stage II prostate cancer
stage III 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