Inclusion Criteria:

- Has given written informed consent before any trial-related activity is performed.

- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all
stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA
after prostatectomy or radiotherapy)

- Is a male patient aged 18 years or older

- Has a screening serum testosterone level >1.5 ng/mL

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

- Has a screening PSA value of ≥2 ng/mL

- Has a life expectancy of at least 12 months

Exclusion Criteria:

- Has had previous or is currently under hormonal management of prostate cancer.
However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant
hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months
prior to Screening Visit

- Is currently treated with a 5-α-reductase inhibitor

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

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

- Has hypersensitivity towards any component of the investigational medicinal product

- A marked baseline prolongation of QT/QTcF interval

- A history of additional risk factors for Torsade de Pointes ventricular arrhythmias

- Has had cancer within the last five years except prostate cancer and surgically
removed basal or squamous cell carcinoma of the skin

- Has a known or suspect hepatic, symptomatic biliary disease

- Has elevated serum ALT level more than the upper limit of normal or serum total
bilirubin level above the upper level of normal range at the Screening Visit and
confirmed with a second measurement within 21 days

- Has other clinically significant laboratory abnormalities

- Has a clinically significant disorder (other than prostate cancer) or any other
condition, including alcohol or drug abuse

- Has a mental incapacity or language barriers precluding adequate understanding or co-
operation

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

- Has previously participated in any degarelix trial