Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Radiation Therapy Oncology Group
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 May 16, 2013