Has a histologically confirmed adenocarcinoma of the prostate for which endocrine treatment (except for neoadjuvant hormonal therapy) is indicated (this includes patients having undergone prostatectomy, cryotherapy or radiotherapy with curative intention and have a rising PSA). For patients having undergone prostatectomy/cryotherapy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy for a maximum duration of six months is accepted. This treatment should have been terminated at least six months prior to the Screening Visit.
Has a PSA level meeting one of these criteria:
For treatment-naïve patients: Patients should have a screening PSA level of >2 ng/mL.
For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of >0.2 ng/mL from the previous test on two consecutive measurements.
For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.
Has a life expectancy of at least one year
No previous or current hormonal management of prostate cancer, surgical castration, or other hormonal manipulation
Has not received therapy with the 5-alpha reductase inhibitors finasteride and dutasteride within twelve weeks and twenty-five weeks, respectively, prior to screening
No previous history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
No history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
No 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
Must have completely recovered from the effects of any major surgery
Has not previously participated in any degarelix trial
Duration of Study Each patient will be treated for thirteen treatment months (of 28 days), i.e. 364 days.
