Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Inclusion Criteria:

• Written informed consent prior to any study related procedures
• Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
• ECOG score to be equal to or above 2
• Testosterone level within age-specific normal range
• PSA value equal to or above 2 ng/ml
• Life expectancy of at least 6 months

Exclusion Criteria:

• Previous or current hormonal treatment of prostate cancer
• Recent or current treatment with any drugs modifying the testosterone level
• Candidate for curative treatment such as prostatectomy or radiotherapy
• History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
• Hypersensitivity towards any component of degarelix or mannitol
• Cancer disease within the last 5 years except for prostate cancer and some skin cancers
• Signs of liver impairment shown as elevated serum ALT or serum bilirubin
• Known hepatic disease
• Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
• Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
• Mental incapacity or language barrier precluding adequate understanding or cooperation
• Having received an investigational product within the last 12 weeks preceding the trial
• Previous participation in this trial