An Open-Label, Multi-Centre, Randomised Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens of 240 mg (40 mg/mL) and 240 mg (60 mg/mL) in Patients with Prostate Cancer Requiring Androgen Ablation Therapy

• Conditions: Prostate Cancer; MedDRA version: 7.0Level: pr tClassification code 10060862

• Registration Number: EUCTR2004-003815-22-FI
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-01
• Last Update Posted: 23 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

•Has given written consent before any study-related activity is performed. A study-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 prostate (all stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention.
•Is a male patient aged 18 years or over.
•Has a baseline serum testosterone level above the lower limit of normal range.
•Has an ECOG score of <=2.
•Has a PSA value of >=2 ng/mL.
•Has a life expectancy of at least 13 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Has had previous or is currently under hormonal management of prostate cancer
•Is considered to be a candidate for curative therapy within 13 months from Screening Visit
•Has a history of, or predisposition to, severe hypersensitivity reactions such as severe asthma, anaphylactic reactions, or chronic or recurrent urticaria and/or angioedema
•Has hypersensitivity towards any component of the investigational medicinal product
•Has had a cancer disease within the last 5 years except from prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
•Has a known or suspected hepatic or symptomatic biliary disease
•Has elevated serum ALT level above upper level of normal range or serum toltal bilirubin level above upper level of normal range at the Screening Visit
•Has other clinically significant laboratory abnormalities, which in the judgement of the investigator would interfere with the patient's participation in this study or evaluation of study results
•Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator
•Has a mental incapacity or language barriers precluding adequate understanding or co-operation.
•Has received an investigational drug within the last 28 days preceeding Screening Visit or longer if considered by the investigator to possibly influence the outcome of the current study
•Has previously participated in any degarelix study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To demonstrate that the efficacy in achieving and maintaining testosterone castration levels (<=0.5 ng/mL) in prostate cancer patients treated up to either 12 or 13 months is at least 80%.;Secondary Objective: •To compare the overall testosterone response up to either 12 or 13 months of treatment. <br>•To compare the PSA response up to either 12 or 13 months of treatment. <br>•To compare the time to disease progression (PSA progression, death from any cause, introduction of additional therapy related to the prostate cancer).<br>•To evaluate safety and tolerability profiles.<br>•To evaluate pharmacokinetic (degarelix) and pharmacodynamic (testosterone) response.;Primary end point(s): •Proportion of patients with testosterone level <=0.5 ng/mL from Day 28 until end of study<br><br><br>