Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00899912

Run by

Radiation Therapy Oncology Group

People needed

13

Starts

2006-06-01

Expected to finish

2013-11-01

Last updated by the study team

2015-11-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• Georgia Cancer Center for Excellence at Grady Memorial Hospital — Atlanta, Georgia, United States
• Emory Crawford Long Hospital — Atlanta, Georgia, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Cancer Institute at St. John's Hospital — Springfield, Illinois, United States
• Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• Barnes-Jewish West County Hospital — St Louis, Missouri, 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

Full record on ClinicalTrials.gov

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