Inclusion Criteria

• Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4,
non-metastatic (M0) prostate cancer with PSA > 60 ng/mL T3-T4, non-metastatic (M0)
prostate cancer with PSA > 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2
Written informed consent

• Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria
of the run-in period Patients who completed the 24-week run-in period Patients who
responded to the 24-week run-in period with a decrease of PSA to < 10 ng/mL. If the
baseline was < 20ng/mL, at least 50% decrease from the baseline measurement is required

Exclusion Criteria (run-in period):

Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase
inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex
hormone status

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