Eur Urol. 2009;55:1269-1277

Intermittent hormonal therapy (IHT) for men with locally advanced and metastatic prostate cancer is associated with no reduction in disease progression or survival, according to a European study.

Fernando E.C. Calais da Silva, MD, of Centro Hospitalar de Lisboa Central in Lisbon,  and colleagues recruited 766 men with locally or advanced prostate cancer who received an initial three-month induction treatment. During induction, all subjects received cyproterone acetate (CPA) 200 mg for two weeks and then monthly depot injections of a luteinizing hormone-releasing hormone (LHRH) analog plus 200 mg of CPA daily.

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After three months, the 626 patients who experienced a decline in PSA level to less than 4 ng/mL or to 80% below the initial value were randomized to receive intermittent (314 patients) or continuous treatment (312 patients). The intermittent arm ceased treatment whereas the continuous arm received 200 mg CPA daily plus an LHRH analog.

In the intermittent arm, 127 men progressed and 170 died; in the continuous arm, 107 progressed and 169 died. None of the differences between the groups was statistically significant. The intermittent arm had a greater number of cancer-related deaths (106 vs. 84), but the continuous arm had more cardiovascular-related deaths (52 vs. 41). Men in the intermittent group reported better sexual function. The median time off therapy in the intermittent group was 52 weeks.