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

Phase 2 Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix Versus Goserelin Depot (Zoladex®) 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 Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Ozarelix; Drug: Goserelin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients, aged 18 years or older, with histologically proven prostate cancer of any stages, for whom endocrine treatment is indicated.
• Screening testosterone > 1.5 ng/ml
• Life expectancy of at least 12 months
• ECOG score of ≤ 2
• Patient has reviewed and signed Informed consent form
• Patient understands and is willing to comply with the protocol

Exclusion Criteria:

• Any hormone therapy prior to study entrance
• Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge
• History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema
• History of hypersensitivity towards any components of the study drug
• History or presence of any other malignancy other than treated squamous cell /basal cell carcinoma of the skin within the last five years
• ECG at screening showing QTc >450 ms, or family history of long QT syndrome

• Abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial

  • - Has a clinically significant medical condition (other than prostate cancer) including but not limited to: renal, hematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator

• Taking Class IA or Class III antiarrhythmic medication
• Has an intellectual incapacity or language barrier precluding adequate understanding or co-operation
• Has received investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of this trial
• Has previously participated in any Ozarelix trials
• Is part of an ongoing trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozarelix	Drug: Ozarelix; 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	Drug: Goserelin; Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the percentage of patients with testosterone <=0.5ng/mL.	From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in Prostate-Specific Antigen level	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	From baseline to day 14 and day 28

Collaborators and Investigators

• Sponsor: Spectrum Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: SPI-153-10-1