PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in samples from patients treated for prostate cancer on trial ECOG-E9802.

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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–120 year

Sex eligibility

Male

Study type

Observational

About this study

OBJECTIVES:

Primary

To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among patients treated on ECOG-E9802.

Secondary

To characterize the concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory.

OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI Immunology Laboratory. Results are compared between the laboratories.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS: Samples collected on ECOG-E9802 (A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox/TRICOM with GM-CSF in Patients with PSA Progression after Local Therapy for Prostate Cancer)

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Treatment and study plan

laboratory biomarker analysis

Other

Primary outcomes

PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test

Time frame: 12 weeks

Secondary outcomes

Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed

Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of PSA Antibody on E9802: Confirmation and Concordance

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 27, 2012
Registry last updated: May 17, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed