Prostate CancerPhase 2NCT01252693
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
A Phase 2 study testing Ozarelix and Goserelin in people with Prostate Cancer, run by Spectrum Pharmaceuticals, Inc at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ozarelix and Goserelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Urology Clinics of North Texas
Dallas, Texas, 75231
The Urology Center of Colorado
Denver, Colorado, 80211
Urology San Antonio Research
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Ozarelix, Goserelin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzarelixDrug
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.
GoserelinDrug
Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.
| Study group | Role | What they receive |
|---|---|---|
| Ozarelix | Experimental | Not described Receives: Drug: Ozarelix |
| Goserelin | Active comparator | Not described Receives: Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the percentage of patients with testosterone <=0.5ng/mL.
Measured: From Day 28 through Day 84, in men receiving Ozarelix versus Goserelin
Secondary outcomes (1)
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
Measured: From baseline to day 14 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252693
- Sponsor's protocol ID
- SPI-153-10-1
- Status last verified
- Sep 2021
- First submitted
- 1 Dec 2010
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01252693
- Acronym / sponsor ID
- SPI-153-10-1
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2010 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozarelix | Experimental | Drug: Ozarelix |
| Goserelin | Active comparator | Drug: Goserelin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzarelixOzarelix Loading dose of 130 mg SC at randomization will be followed by maintenance dosing of 65 mg SC at day 8, 28 and 56. | Drug | Ozarelix |
| GoserelinGoserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56. | Drug | Goserelin |
Primary outcome
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
1 secondary outcome
Percentage change in Prostate-Specific Antigen level
Time frame: From baseline to day 14 and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ozarelix and Goserelin in people with Prostate Cancer, run by Spectrum Pharmaceuticals, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.