Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA >4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.

Inclusion Criteria:

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment.
• Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be >4 ng/mL and ≤50 ng/mL.
• Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA - PSA doubling time (based on patient records at the trial site) must be <24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL.
• Is a male patient aged 18 years or older.
• Has an Eastern Cooperative Oncology Group score of ≤2.
• Has a life expectancy of at least 24 months.

Exclusion Criteria:

• Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gonadotropin releasing hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit.
• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
• Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Has hypersensitivity towards any component of the investigational medicinal product.
• 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 suspected clinically significant liver and/or biliary disease.
• Has a history of or risk factors for Torsades de Pointes
• At time of inclusion receives concomitant medications that might prolong the QT interval.
• Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient's health or the outcome of the trial.
• Has a clinically significant disorder (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 severe kidney failure (creatinine clearance <30 mL/min), based on the serum creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only valid in France).
• 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