Trials / Completed
CompletedNCT00899912
Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 13 (actual)
- Sponsor
- Radiation Therapy Oncology Group · Network
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | microarray analysis | |
| OTHER | diagnostic laboratory biomarker analysis |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2009-05-12
- Last updated
- 2015-11-17
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00899912. Inclusion in this directory is not an endorsement.