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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006359 |
Purpose
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: bicalutamide Drug: flutamide Drug: goserelin Drug: iodine I 125 Drug: leuprolide acetate Drug: palladium Pd 103 Procedure: brachytherapy Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Iodine Cadexomer iodine Goserelin Leuprolide acetate Leuprolide Flutamide Bicalutamide |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer |
| Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.
Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Must have one of the following prognostic factors:
No distant or nodal metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Delaware | |||||
| Beebe Medical Center | |||||
| Lewes, Delaware, United States, 19958 | |||||
| CCOP - Christiana Care Health Services | |||||
| Newark, Delaware, United States, 19718 | |||||
| St. Francis Hospital | |||||
| Wilmington, Delaware, United States, 19805 | |||||
| United States, Florida | |||||
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |||||
| Orlando, Florida, United States, 32803 | |||||
| United States, Maryland | |||||
| Union Hospital Cancer Center at Union Hospital | |||||
| Elkton MD, Maryland, United States, 21921 | |||||
| United States, Massachusetts | |||||
| Brigham and Women's Hospital | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| Hudner Oncology Center at Saint Anne's Hospital | |||||
| Fall River, Massachusetts, United States, 02721 | |||||
| UMASS Memorial Cancer Center - University Campus | |||||
| Worcester, Massachusetts, United States, 01655 | |||||
| United States, Missouri | |||||
| Arch Medical Services, Incoroporated at Center for Cancer Care Research | |||||
| Saint Louis, Missouri, United States, 63141 | |||||
| Missouri Baptist Cancer Center | |||||
| St. Louis, Missouri, United States, 63131 | |||||
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |||||
| Columbia, Missouri, United States, 65203 | |||||
| CCOP - Kansas City | |||||
| Kansas City, Missouri, United States, 64131 | |||||
| United States, Nevada | |||||
| Washoe Cancer Services at Washoe Medical Center - Reno | |||||
| Reno, Nevada, United States, 89502 | |||||
| United States, New Jersey | |||||
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | |||||
| Camden, New Jersey, United States, 08103 | |||||
| United States, New York | |||||
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |||||
| Syracuse, New York, United States, 13057 | |||||
| Community General Hospital of Greater Syracuse | |||||
| Syracuse, New York, United States, 13215 | |||||
| Veterans Affairs Medical Center - Syracuse | |||||
| Syracuse, New York, United States, 13210 | |||||
| SUNY Upstate Medical University Hospital | |||||
| Syracuse, New York, United States, 13210 | |||||
| Roswell Park Cancer Institute | |||||
| Buffalo, New York, United States, 14263 | |||||
| United States, North Carolina | |||||
| Comprehensive Cancer Center at Wake Forest University | |||||
| Winston-Salem, North Carolina, United States, 27157 | |||||
| Presbyterian Cancer Center at Presbyterian Hospital | |||||
| Charlotte, North Carolina, United States, 28233 | |||||
| Wayne Memorial Hospital, Incorporated | |||||
| Goldsboro, North Carolina, United States, 27534 | |||||
| Zimmer Cancer Center at New Hanover Regional Medical Center | |||||
| Wilmington, North Carolina, United States, 28401 | |||||
| United States, Ohio | |||||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |||||
| Columbus, Ohio, United States, 43210 | |||||
| United States, Virginia | |||||
| Danville Regional Medical Center | |||||
| Danville, Virginia, United States, 24541 | |||||
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Mark Hurwitz, MD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination External Beam Radiation and Brachytherapy Boost with Androgen Suppression for Treatment of Intermediate-Risk Prostate Cancer: An Initial Report of Calgb 99809. Int J Radiat Oncol Biol Phys. 2008 Apr 11; [Epub ahead of print]
  |
|
Hurwitz MD, Halabi S, Ou SS, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate risk prostate cancer: an initial report of CALGB 99-809. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2230, S337-8, 2006.
  |
| Study ID Numbers: | CDR0000068228, CALGB-99809 |
| First Received: | October 4, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006359 |
| Health Authority: | United States: Federal Government |
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