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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ozarelix
Goserelin
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Urology Center of Colorado
  • Urology Clinics of North Texas
  • Urology San Antonio Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ozarelix

Goserelin

Arm Description

Outcomes

Primary Outcome Measures

To assess the percentage of patients with testosterone <=0.5ng/mL.

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2010
Last Updated
September 30, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01252693
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozarelix
Arm Type
Experimental
Arm Title
Goserelin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ozarelix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Goserelin
Intervention Description
Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage change in Prostate-Specific Antigen level
Description
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
Time Frame
From baseline to day 14 and day 28

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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