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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-99809 | |||
| CDR0000068228 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androgen suppression + EBRT + Brachytherapy | Experimental | Androgen suppression with external beam radiation therapy followed by brachytherapy boost |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LHRH agonist | Drug | Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | q 3 mon for 2 yrs post tx initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA failure | 6 years | |
| Survival | Progression free and overall survival will be assessed | 6 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Must have one of the following prognostic factors:
Prostate volume < 60 cc by transrectal ultrasound
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Hurwitz, MD | Dana-Farber/Brigham and Women's Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beebe Medical Center | Lewes | Delaware | 19958 | United States | ||
| CCOP - Christiana Care Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010. | ||
| 18407435 | Result | 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 Nov 1;72(3):814-9. doi: 10.1016/j.ijrobp.2008.01.010. Epub 2008 Apr 11. |
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| antiandrogen | Drug | flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks |
|
| radiation therapy | Radiation | 4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions) |
|
| Brachytherapy boost | Radiation | Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy |
|
| Newark |
| Delaware |
| 19718 |
| United States |
| St. Francis Hospital | Wilmington | Delaware | 19805 | United States |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Union Hospital Cancer Center at Union Hospital | Elkton MD | Maryland | 21921 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Hudner Oncology Center at Saint Anne's Hospital | Fall River | Massachusetts | 02721 | United States |
| UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Arch Medical Services, Incoroporated at Center for Cancer Care Research | St Louis | Missouri | 63141 | United States |
| Washoe Cancer Services at Washoe Medical Center - Reno | Reno | Nevada | 89502 | United States |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden | New Jersey | 08103 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13057 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| Community General Hospital of Greater Syracuse | Syracuse | New York | 13215 | United States |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D000726 | Androgen Antagonists |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D006727 | Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013812 | Therapeutics |
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