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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
diagnostic procedure
molecular diagnostic method
protein expression analysis
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    September 25, 2007
    Last Updated
    March 14, 2012
    Sponsor
    National Institutes of Health Clinical Center (CC)
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00535834
    Brief Title
    Studying Stored Samples From Patients With Localized Prostate Cancer Treated on Clinical Trial NCI-00-C-0154
    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
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institutes of Health Clinical Center (CC)
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

    7. Study Design

    Enrollment
    48 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    diagnostic procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    molecular diagnostic method
    Intervention Type
    Procedure
    Intervention Name(s)
    protein expression analysis
    Primary Outcome Measure Information:
    Title
    Immunologic response
    Title
    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 Measure Information:
    Title
    Cloning of any underlying tumor antigens discovered in this process

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James Gulley, MD, PhD
    Organizational Affiliation
    National Cancer Institute (NCI)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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