Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

• Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline [ Time Frame: Day 0 (baseline), 1 month ] [ Designated as safety issue: No ]

  Response to treatment was defined as:

  • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
  • No response (increase): Difference > +10% of Baseline level.

  Per protocol, the one month timeframe was only analyzed for cohort 2.

• Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline [ Time Frame: Day 0 (baseline), 2 months ] [ Designated as safety issue: No ]

  Response to treatment was defined as:

  • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
  • No response (increase): Difference > +10% of Baseline level.

  Per protocol, the two month timeframe was only analyzed for cohort 2.

• Participants at Testosterone Castrate Level Throughout the Study [ Time Frame: up to month 12 ] [ Designated as safety issue: No ]
  Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.
• Change From Baseline in Serum Levels of Testosterone at the Last Visit [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ] [ Designated as safety issue: No ]
• Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ] [ Designated as safety issue: No ]
• Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ] [ Designated as safety issue: No ]
  LH is measured in IU/L
• Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ] [ Designated as safety issue: No ]
• Participants at Testosterone Level <=0.2 ng/mL Throughout the Study [ Time Frame: up to month 12 ] [ Designated as safety issue: No ]
  Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
• Participants at Testosterone Level <=0.32 ng/mL Throughout the Study [ Time Frame: up to month 12 ] [ Designated as safety issue: No ]
  Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
• Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study [ Time Frame: up to month 12 ] [ Designated as safety issue: No ]
  Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.
• Kaplan-Meier Estimate for Overall Survival [ Time Frame: up to month 12 ] [ Designated as safety issue: No ]
  The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

Inclusion Criteria:

• Patient has given written informed consent before any trial-related activity is performed.
• Patient is 18 years or older.
• Histologically confirmed prostate cancer.
• Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
• Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
• Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Estimated life expectancy at least 12 months.

Exclusion Criteria:

• 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.
• Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
• Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
• Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
• Known hypersensitivity towards any component of the investigational medical product.
• History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Known or suspected clinically significant liver and/or biliary disease.
• Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, 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.
• Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
• Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
• Previous participation in any degarelix trial.