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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) National Cancer Institute of Canada |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023829 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.)
PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: bicalutamide Drug: flutamide Procedure: adjuvant therapy Procedure: radiation therapy Procedure: releasing hormone agonist therapy |
Phase III |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Flutamide Bicalutamide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer |
| Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10 ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm III closed to accrual as of 12/9/2002.)
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)
Eligibility
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
High-risk for PSA relapse as defined by Gleason score 7 or higher and ≥ 1 of the following OR Gleason score < 7 and ≥ 2 of the following:
Negative lymph node status by lymph node sampling or dissection
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Canada, Ontario | |||||
| Toronto Sunnybrook Regional Cancer Centre | |||||
| Toronto, Ontario, Canada, M4N 3M5 | |||||
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| National Cancer Institute of Canada |
| Study Chair: | Richard K. Valicenti, MD | Kimmel Cancer Center (KCC) |
| Study Chair: | Richard Choo, MD | Edmond Odette Cancer Centre at Sunnybrook |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068868, RTOG-P-0011, RTOG-DEV-1037, CAN-NCIC-PR9 |
| First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00023829 |
| Health Authority: | United States: Federal Government |
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