An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen with Goserelin Acetate in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

• Conditions: prostate cancer; MedDRA version: 9.1Level: PTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2008-005276-27-BE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 825

Inclusion Criteria

1. 18 years or older.
2. Has a histological confirmed prostate cancer Gleason graded).
3. Has a screening testosterone above 1.5 ng/mL.
4. Rising PSA.
5. Has Eastern Cooperative Oncology Group (ECOG) score of = 2.
6. Has a life expectancy of at least one year.
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

1. Current or previous hormone therapy.
2. Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
3. Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
4. Has a heart insufficiency.
5. Has a 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.
6. Has a clinically significant medical condition (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.
7. Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
8. Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Testosterone level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: No ];Secondary Objective: Testosterone level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: No ]<br><br>PSA level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: Yes ]<br><br>Reported Quality of Life - SF36 [ Time Frame: At baseline, 10 months and 13 months ] [ Designated as safety issue: No ]<br><br>Reported Quality of Life - IPPS [ Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months ] [ Designated as safety issue: No ]<br><br>;Primary end point(s): Testosterone level [ Time Frame: Every month during one year of treatment ] [ Designated as safety issue: No ]