The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

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 was a three-arm, active-control, multi-centre, parallel group study.

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: Leuprolide 7.5 mg
  • Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: degarelix 240/160 mg
  • 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: degarelix 240/80 mg
  • 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: Leuprolide 7.5 mg
  • Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.

Primary Measures

• Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
  • Time Frame: 2 weeks
    Safety Issue?: No
• Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
  • Time Frame: 3 days
    Safety Issue?: No
• Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
  • Time Frame: Day 252, Day 255, and Day 259
    Safety Issue?: No
• Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
  • Time Frame: Days 14 and 28
    Safety Issue?: No
• Participants Grouped by Time to Prostate-specific Antigen Failure
  • Time Frame: 12 months
    Safety Issue?: No
• Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
  • Time Frame: Baseline to Day 364
    Safety Issue?: No
• The Mean Value of QTc Interval as Measured by Electrocardiogram
  • Time Frame: 12 months
    Safety Issue?: No
• Participants With Markedly Abnormal Change in Vital Signs and Body Weight
  • Time Frame: 12 months
    Safety Issue?: No

Main Inclusion Criteria:

• Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
• Baseline testosterone >1.5 ng/mL.
• 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 Investigator: Ferring Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Clinical Development Support Study Director Ferring Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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