Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899912
• Other study ID #: RTOG-0612
• Secondary ID: CDR0000490025NCI
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 14, 2015
• Start date: June 2006
• Est. completion date: November 2013

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• microarray analysis

Other:
• diagnostic laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Georgia Cancer Center for Excellence at Grady Memorial Hospital	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	MedCentral - Mansfield Hospital	Mansfield	Ohio
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Barnes-Jewish West County Hospital	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters	Saint Peters	Missouri
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis		Specimens collected at the time of brachytherapy	No
Secondary	Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232		After microarray analysis of tissue and primary endpoint analysis of RTOG 0232	No
Secondary	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		After microarray analysis of tissue and primary endpoint analysis of RTOG 0232	No
Secondary	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		After microarray analysis of tissue and primary endpoint analysis of RTOG 0232	No