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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00535834
Enrollment
48
Registered
2007-09-26
Start date
Unknown
Completion date
2011-03-31
Last updated
2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

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.

Interventions

PROCEDUREprotein expression analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Cloning of any underlying tumor antigens discovered in this process

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026