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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005044 |
RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: bicalutamide Drug: flutamide Procedure: neoadjuvant therapy Procedure: radiation therapy Procedure: releasing hormone agonist therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer |
Study Start Date: | February 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Intermediate risk for disease relapse as determined by any of the following combination of factors:
Clinically negative lymph nodes (N0) as established by imaging or negative lymph nodes by nodal sampling or dissection
No distant metastases (M0)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide provided:
Radiotherapy:
Surgery:
Other:
Study Chair: | Michael G. Haddock, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067635, RTOG-9910 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005044 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Bicalutamide Urogenital Neoplasms |
Flutamide Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Androgen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |