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Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter. The relationship between long-term use of Avodart and male breast neoplasia is currently unknown. During the double-blind treatment period, 2,167 male subjects were exposed to Avodart, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. These data suggest that Avodart arrests the disease process of BPH in men with an enlarged prostate. 57) mL/sec for tamsulosin, with a mean difference between combination and Avodart of 0. Therefore, for interpretation of serial PSAs in a man taking Avodart, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA.

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