NCT00535834

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

First QC Date

September 25, 2007

Last Update Submit

March 14, 2012

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage II prostate cancerstage III prostate canceradenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Cloning of any underlying tumor antigens discovered in this process

Interventions

diagnostic procedurePROCEDURE
molecular diagnostic methodPROCEDURE
protein expression analysisPROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Molecular Diagnostic Techniques

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic Techniques

Study Officials

  • James Gulley, MD, PhD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Completion

March 1, 2011

Last Updated

March 16, 2012

Record last verified: 2012-03