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Completed

NCT Number: NCT00535834

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic procedure

Procedure

molecular diagnostic method

Procedure

protein expression analysis

Procedure

Primary outcomes

  1. Immunologic response

  2. 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 outcomes

  1. Cloning of any underlying tumor antigens discovered in this process

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study completion
2011
First posted
Sep 26, 2007
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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