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
September 30, 2021 updated by: Spectrum Pharmaceuticals, Inc
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80211
- The Urology Center of Colorado
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Texas
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Dallas, Texas, United States, 75231
- Urology Clinics Of North Texas
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San Antonio, Texas, United States, 78229
- Urology San Antonio Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ozarelix
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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
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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.
Time Frame: From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin
|
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
Time Frame: From baseline to day 14 and day 28
|
Additional secondary outcomes:
|
From baseline to day 14 and day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- SPI-153-10-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.