Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00899912|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 17, 2015
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 or disease||Intervention/treatment|
|Prostate Cancer||Genetic: microarray analysis Other: diagnostic laboratory biomarker analysis|
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
- Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis [ Time Frame: Specimens collected at the time of brachytherapy ]
- Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232 [ Time Frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232 ]
- 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 [ Time Frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232 ]
- 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 [ Time Frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232 ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT00899912
|United States, Georgia|
|Georgia Cancer Center for Excellence at Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Emory Crawford Long Hospital|
|Atlanta, Georgia, United States, 30308|
|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|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|Barnes-Jewish West County Hospital|
|Saint Louis, Missouri, United States, 63141|
|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|
|Study Chair:||Arnab Chakravarti, MD||Ohio State University|