Inclusion Criteria:

- Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all
stages

- Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA
after having prostatectomy or radiotherapy performed with curative intention may be
included

- Has a serum testosterone level above 1.5 ng/mL at screening

- Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of
0 to 2

Exclusion Criteria:

- Previous or present endocrine treatment for prostate cancer. However, patients who
have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6
months and in whom prostatectomy or radiotherapy was terminated at least 6 months
preceding Screening Visit may be included

- Is being treated with a 5α-reductase inhibitor

- Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy
within 12 months

- Has concurrent or a history of severe asthma (defined as a need for daily treatment
with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema