Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899912
First received: May 9, 2009
Last updated: March 20, 2012
Last verified: October 2011
  Purpose

RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in patients with prostate cancer.


Condition Intervention
Prostate Cancer
Genetic: microarray analysis
Other: diagnostic laboratory biomarker analysis

Study Type: Observational
Official Title: Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232 [ Designated as safety issue: No ]
  • Comparison of genes to determine which are expressed differentially before and after radiotherapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232 [ Designated as safety issue: No ]
  • Gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: June 2006
Detailed Description:

OBJECTIVES:

Primary

  • Demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded, to yield RNA of adequate quality to perform DNA microarray studies on markers of radiotherapy outcome in patients with intermediate-risk prostate cancer.

Secondary

  • Compare the gene expression results from frozen tissue and paraffin-embedded tissue to see the correlation between the 2 methods in patients treated on the brachytherapy alone arm of protocol RTOG-0232.
  • Find genes that are expressed differentially before and after radiation therapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232.
  • Find gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure.

OUTLINE: This is a multicenter, pilot study.

Frozen and paraffin-embedded tissue samples are studied for biomarker/laboratory analysis. DNA microarray analysis is performed on the samples to assess markers of radiotherapy outcome.

PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer

    • Stage II disease
    • Adenocarcinoma
  • Eligible for and enrolled on protocol RTOG 0232
  • Able to submit frozen tissue cores from biopsy specimens obtained at the time of brachytherapy

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior neoadjuvant hormonal therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899912

Locations
United States, Georgia
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Missouri
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
Saint Peters, Missouri, United States, 63376
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Arnab Chakravarti, MD Ohio State University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899912     History of Changes
Other Study ID Numbers: CDR0000490025, RTOG-0612
Study First Received: May 9, 2009
Last Updated: March 20, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014