Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer

Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer

Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.

Inclusion Criteria:

• Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated

• Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan

• Has a PSA level meeting one of these criteria:

  1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
  2. 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
  3. 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 screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL

• Has an Eastern Cooperative Oncology Group score of ≤2

• Has a life expectancy of at least one year

Exclusion Criteria:

• Has had previous or is currently under hormonal management of prostate cancer
• Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
• Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
• Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
• Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
• Has a previous history or presence of another malignancy, other than prostate
• Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
• Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial