Status:
COMPLETED
Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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 ide...
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 radiothe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00899912
Start Date
June 1 2006
End Date
November 1 2013
Last Update
November 17 2015
Active Locations (10)
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1
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702