International,Multi-Center,Open Label,Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot in Men With Prostate Cancer
The aim of this study is to assess the safety and efficacy of a monthly regimen of ozarelix administered subcutaneously (SC) versus Goserelin depot administered subcutaneously in men with Prostate Cancer. This is an international, multi-center, randomized, open label 84 days study. Men who are at least 18 years of age or older, with histologically proven prostate cancer of all stages, in whom endocrine treatment is indicated will be eligible for study entry.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot (Zoladex®) in Men With Prostate Cancer|
- To assess the percentage of patients with testosterone <=0.5ng/mL. [ Time Frame: From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin ] [ Designated as safety issue: Yes ]
- Percentage change in Prostate-Specific Antigen level [ Time Frame: From baseline to day 14 and day 28 ] [ Designated as safety issue: Yes ]
Additional secondary outcomes:
- Percentage of patients with testosterone level <=0.5 ng/mL at day 3
- Median time to reach 50% suppression of baseline Prostate Specific Antigen level
- Percentage of patients with testosterone surge ("hormone escape") during the first two weeks of treatment
- To assess the safety of Ozarelix SC monthly dosing compared to Goserelin depot SC monthly dosing in men with Prostate Cancer
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Ozarelix Loading dose of 130 mg SC at randomization will be followed by maintenance dosing of 65 mg SC at day 8, 28 and 56.
|Active Comparator: Goserelin||
Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.
Prospective study subjects will undergo screening procedures. Approximately 214 eligible patients will enter the study. Patients will be randomized in a 1:1 ratio to one of two treatment arms (Ozarelix or Goserelin). Eligible patients randomized to the ozarelix group will receive two SC injections of ozarelix 65 mg in the abdomen on Day 1 (left lower quadrant, LLQ and right lower quadrant, RLQ), followed by a SC injection of 65 mg of Ozarelix (abdomen LLQ) on day 8 and will receive 2 additional SC injections of Ozarelix on days 28 and 56 (alternating injection sites). Eligible patients randomized to Goserelin will receive one 3.6 mg SC injection in the abdomen (LLQ or RLQ), followed by a 3.6 mg SC injection on Days 28 and 56 (alternating injection sites). Ozarelix will be reconstituted and administered as a 65 mg injection. Patients will receive two Ozarelix 65 mg subcutaneous injections (SC) on Day 1, and one 65 mg SC injection on day 8, followed by one 65 mg injection on days 28 and 56. The patients will receive one Goserelin 3.6 mg SC injection at baseline, Day 28 and Day 56.
|United States, Colorado|
|The Urology Center of Colorado|
|Denver, Colorado, United States, 80211|
|United States, Texas|
|Urology Clinics of North Texas|
|Dallas, Texas, United States, 75231|
|Urology San Antonio Research|
|San Antonio, Texas, United States, 78229|
|Study Director:||Pankaj Sharma, MD||Spectrum Pharmaceuticals, Inc|