Inclusion Criteria:

- 18 years or older.

- Has a histological confirmed prostate cancer Gleason graded).

- Has a screening testosterone above 2.2 ng/mL.

- Rising PSA.

- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.

- Has a life expectancy of at least one year.

Exclusion Criteria:

- Current or previous hormone therapy.

- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks,
respectively, prior to screening.

- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema.

- Has a heart insufficiency.

- Has a previous history or presence of another malignancy, other than prostate cancer
or treated squamous/basal cell carcinoma of the skin, within the last five years.

- Has a clinically significant medical condition (other than prostate cancer)
including, but not limited to, renal, haematological, gastrointestinal, endocrine,
cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other
condition which may affect the patient's health or the outcome of the trial as judged
by the Investigator.

- Has received an investigational drug within the last 28 days before the Screening
Visit or longer if considered to possibly influencing the outcome of the current
trial.

- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.