Inclusion Criteria:

- Histologically or cytologically proven prostate cancer.

- Prostate cancer stage T3-4NxMx, TxN1Mx or TxNxM1 according to the TNM classification
(see Appendix A: TNM Classification) or the patient should have rising PSA after
failed local therapy and be candidate for androgen deprivation therapy.

- Serum testosterone levels > 5 nmol/L.

- Karnofsky performance index > 40 (see Appendix B: Karnofsky Performance Scale).

- Expected survival > 18 months.

- Absence of another malignancy, other than local dermatological, for the previous 5
years.

- Signed informed consent before entry into the study.

Exclusion Criteria:

- Prior hormonal treatment for prostate cancer within 6 months prior to study start.

- Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior
to study start.

- Presence of another neoplastic lesion or brain metastases.

- Prior hypophysectomy or adrenalectomy.

- Known or suspicion of vertebral metastases with risk of spinal compression.

- Severe kidney or liver failure (creatinine > 2 x upper limit of normal (ULN),
aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) > 3 x ULN).

- Any concomitant disorder or resulting therapy that is likely to interfere with
patient compliance or with the study in the opinion of the Investigator.

- Participation in another study with an experimental drug within 3 months before study
start or within 5 drug half-lives of the investigational drug (whichever is the
longer).

- Known hypersensitivity to any of the test materials or related compounds.

- Known active use of recreational drug or alcohol dependence in the opinion of the
Investigator.

- Any current use or use within 6 months prior to treatment start of medications which
are known to affect the metabolism and/or secretion of androgenic hormones:
ketoconazole, aminoglutethimide, oestrogens, progesterone, and anti-androgens.

- Use of systemic or inhaled corticosteroids (topical application permitted).

- Inability to give informed consent or to comply fully with the protocol.