Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:August 2000
End Date:July 2006

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Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent

RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to
prevent the development of cancer. Flutamide may be effective in the prevention of prostate
cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing
prostate cancer in patients who have neoplasia of the prostate.

OBJECTIVES: I. Determine the ability of flutamide to reduce the incidence of prostate cancer
in patients with high grade prostatic intraepithelial neoplasia. II. Determine the effect of
this regimen on a series of endpoint biomarkers in these patients. III. Assess the quality
of life of these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to age (under 65 versus 65 and over), PSA (0-2.5 versus 2.6-4.0
versus 4.1-10 versus greater than 10 ng/mL), PIN (on one biopsy versus on two biopsies), and
family history (prostate cancer in brother, father, or uncle versus no prostate cancer in
these relatives). Patients are randomized to one of two treatment arms.

DISEASE CHARACTERISTICS: Histologically confirmed high grade prostatic intraepithelial
neoplasia Confirmed by second prostate biopsy within 180 days of first biopsy No prior or
concurrent prostatic carcinoma No prior hormonal replacement or antiandrogen therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Greater than 5 years Hematopoietic: Not specified Hepatic: SGOT and alkaline phosphatase
no greater than 2 times upper limit of normal No hepatitis B or C or liver cirrhosis
Renal: Not specified Other: Fertile patients must use effective contraception No other
prior malignancy in past 5 years except carcinoma in situ or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy
Surgery: Not specified
We found this trial at
23
sites
Saint Louis Park, Minnesota 55416
1505
mi
from 91732
Saint Louis Park, MN
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Ann Arbor, Michigan 48106
1929
mi
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Ann Arbor, MI
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Bismarck, North Dakota 58501
1257
mi
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Bismarck, ND
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Cedar Rapids, Iowa 52403
1529
mi
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Cedar Rapids, IA
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Danville, Pennsylvania 17822
2296
mi
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Danville, PA
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Danville, Pennsylvania 17822
2296
mi
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Danville, PA
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
1422
mi
from 91732
Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
1610
mi
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Duluth, MN
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Fargo, North Dakota 58122
1416
mi
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Fargo, ND
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Grand Forks, North Dakota 58201
1444
mi
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Grand Forks, ND
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New Orleans, Louisiana 70121
1650
mi
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New Orleans, LA
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1297
mi
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Omaha, NE
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1616
mi
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Peoria, IL
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
1049
mi
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Rapid City, SD
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Regina, Saskatchewan
1317
mi
from 91732
Regina,
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
1524
mi
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Rochester, MN
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Saint Cloud, Minnesota 56303
1483
mi
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Saint Cloud, MN
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Scottsdale, Arizona 85259
358
mi
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Scottsdale, AZ
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Sioux City, Iowa 51101
1303
mi
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Sioux City, IA
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Sioux Falls, South Dakota 57104
1314
mi
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Sioux Falls, SD
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1932
mi
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Toledo, OH
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
1685
mi
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Urbana, IL
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Wichita, Kansas 67214
1182
mi
from 91732
Wichita, KS
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