Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

November 14, 2015 updated by: Radiation Therapy Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, United States, 30308
        • Emory Crawford Long Hospital
      • Atlanta, Georgia, United States, 30303
        • Georgia Cancer Center for Excellence at Grady Memorial Hospital
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Cancer Institute at St. John's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Barnes-Jewish West County Hospital
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
      • Mansfield, Ohio, United States, 44903
        • MedCentral - Mansfield Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Intermediate risk prostate cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Specimens collected at the time of brachytherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
After microarray analysis of tissue and primary endpoint analysis of RTOG 0232

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Arnab Chakravarti, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 14, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-0612
  • CDR0000490025
  • NCI-2009-00734 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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