Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00899912
First received: May 9, 2009
Last updated: May 16, 2014
Last verified: May 2014
  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
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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 ] [ 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 [ Time Frame: After microarray analysis of tissue and primary endpoint analysis of 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 [ Time Frame: After microarray analysis of tissue and primary endpoint analysis of 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 [ Time Frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Frozen tissue cores of prostatic biopsy specimens


Enrollment: 13
Study Start Date: June 2006
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Intermediate risk prostate cancer patients

Criteria

Inclusion Criteria:

  • Histologically confirmed, locally confined adenocarcinoma of the prostate
  • Zubrod performance 0-1
  • Clinical stages T1c - T2b, N0, M0
  • Combined Gleason score 7 if prostate specific antigen (PSA) < 10, combined Gleason score < 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.
  • American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).
  • Age ≥ 18 years old and must sign a study-specific informed consent form

Exclusion Criteria:

  • No clinically or pathologically involved lymph nodes
  • No distant metastases or significant obstructive symptoms
  • No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed.
  • No previous hormonal therapy beginning < 2 months or > 6 months prior to registration is allowed.
  • No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
  • No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00899912     History of Changes
Other Study ID Numbers: RTOG-0612, CDR0000490025, NCI-2009-00734
Study First Received: May 9, 2009
Last Updated: May 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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 September 18, 2014