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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672905
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : May 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment
Prostate Cancer Other: laboratory biomarker analysis

Detailed Description:



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


  • 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.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of PSA Antibody on E9802: Confirmation and Concordance
Actual Study Start Date : December 7, 2012
Actual Primary Completion Date : January 7, 2013
Actual Study Completion Date : January 7, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients who participated in E9802 and provided samples for research

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)


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672905

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey

Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT01672905     History of Changes
Other Study ID Numbers: CDR0000738979
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
recurrent prostate cancer
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs