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

This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: September 25, 2007
Last updated: March 14, 2012
Last verified: March 2012

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:



  • 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.


  • 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.


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


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


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


  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its identifier: NCT00535834

Sponsors and Collaborators
Principal Investigator: James Gulley, MD, PhD National Cancer Institute (NCI)
  More Information

No publications provided Identifier: NCT00535834     History of Changes
Other Study ID Numbers: 999907214, 07-C-N214, CDR0000565972
Study First Received: September 25, 2007
Last Updated: March 14, 2012
Health Authority: Unspecified

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
Genital Diseases, Male
Prostatic Diseases processed this record on April 15, 2014