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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis

Safety Issue:

No

Principal Investigator

Arnab Chakravarti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University

Authority:

United States: Federal Government

Study ID:

CDR0000490025

NCT ID:

NCT00899912

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
MedCentral - Mansfield Hospital Mansfield, Ohio  44903
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Georgia Cancer Center for Excellence at Grady Memorial Hospital Atlanta, Georgia  30303
Emory Crawford Long Hospital Atlanta, Georgia  30308
Barnes-Jewish West County Hospital Saint Louis, Missouri  63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters Saint Peters, Missouri  63376