Official Title: “An Open-Label, Multi-Centre, Randomized, Parallel-Group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy”

The study will be a three-arm, active-control, multi-centre, parallel group study.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: Degarelix
  • Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
• Drug: Degarelix
  • Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
• Drug: Lupron Depot
  • Lupron Depot 7.5mg IM (in the muscle every 28 days starting at day 0.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
• Experimental: B
  • Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
• Active Comparator: C
  • Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Primary Measures

• To demonstrate non-inferiority with respect to the proportion of patients achieving and maintaining testosterone suppression to castrate levels using a degarelix dosing regimen compared to LUPRON DEPOT® during 12 months treatment

Secondary Measures

• To compare serum levels of testosterone and PSA using a degarelix dosing regimen versus LUPRON DEPOT® during the first 28 days of treatment

DIAGNOSIS AND MAIN CRITERIA FOR INCLUSION:

• Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
• Baseline testosterone above the lower limit of normal rang. Life expectancy of at least 12 months.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ferring Pharmaceuticals

Overall Clinical Trial Officials and Contacts

James Walker, Pharm.D., M.S. Study Director Ferring Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295750

Study ID Number: FE200486 CS21

ClinicalTrials.gov Identifier: NCT00295750

Health Authority: United States: Food and Drug Administration