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Patients must have histopathological documentation of prostate cancer confirmed in the Pathology Department of the Clinical Center at the National Institutes of Health or the National Naval Medical Center prior to starting this study.

The authors suggest that patients utilize birth control while on this medication; regularly testing urine or serum human chorionic gonadotropin (HCG) along with other laboratory tests, such as potassium and creatinine, is appropriate.

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Patients who do not experience bad side effects and whose tumor does not grow during the first 3 treatment cycles will continue treatment; those who experience unacceptable side effects will be taken off the study.

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