Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

NCT00899912 | Completed DMC

• 3 other identifiers: RTOG-0612CDR0000490025NCI-2009-00734
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

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

  Specimens collected at the time of brachytherapy

Secondary Outcomes (3)

• 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

• 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

• 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

Interventions

microarray analysis GENETIC

diagnostic laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intermediate risk prostate cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Barnes-Jewish West County Hospital

St Louis, Missouri, 63141, United States

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210-1240, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Frozen tissue cores of prostatic biopsy specimens

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Microarray Analysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques

Study Officials

• Arnab Chakravarti, MD

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: June 1, 2006
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (10)