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Vol. 33, No. 2, 1998
Issue release date: February 1998
Eur Urol 1998;33:144–151

Maximal Androgen Blockade: Final Analysis of EORTC Phase III Trial 30853

Denis L.J. · Keuppens F. · Smith P.H. · Whelan P. · Carneiro de Moura J.L. · Newling D. · Bono A. · Sylvester R.
Departments of Urology, A.Z. Middelheim, Antwerp, and Vrije Universiteit, Brussels, Belgium;St. James’ University Hospital, Leeds, UK;Hospital Santa Maria, Lisbon, Portugal;Free University Hospital, Amsterdam, The Netherlands;Ospedale di Circolo e Fondazione E.S. Macchi, Varese, Italy;EORTC Data Center, Brussels, Belgium

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Objectives: This prospective, randomized phase III study was initiated to compare the efficacy and side effects of bilateral orchiectomy versus a combination of a luteinizing hormone-releasing hormone agonist depot formulation, goserelin acetate (3.6 mg s.c. once every 4 weeks) and flutamide (250 mg 3× daily) in patients with metastatic prostate cancer. Methods: Relative treatment efficacy was assessed by comparing the two treatment groups with respect to response, time to first progression, progression-free survival, duration of survival and time to death due to malignant disease. Results: There was a difference in response only with respect to a more frequent decrease to normal of the serum prostate acid phosphatase in patients assigned to maximal androgen blockade treatment. Additionally, maximal androgen blockade treatment showed significantly better results for duration of survival (p = 0.04), time to death due to malignant disease (p = 0.008), time to first progression (p = 0.009) and progression-free survival (p = 0.02). The most frequent side effects for both treatments included hot flushes and gynaecomastia. Conclusions: Increased time to progression and duration of survival is achieved by the combination of flutamide and goserelin when compared to bilateral orchiectomy.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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    External Resources

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    External Resources

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    External Resources

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    External Resources

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