Prostate CancerPhase 3NCT00841113
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
A Phase 3 study testing Abarelix and Goserelin plus Bicalutamide in people with Prostate Cancer, run by Speciality European Pharma Limited.
Trial summary
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer. 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?
- Abarelix and Goserelin plus Bicalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Feb 2003
- Phase
- Phase 3
- 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
- Histologically proven prostate cancer and not previously treated with hormones
- Evidance of advanced disease or metastases
- Life expentancy of at least 3 months
- Normal serum testosterone levels
- Written informed consent
Who cannot join
- Previous endocrine or cytoxic theapy for prostate cancer
- Known tumour complication of prostate cancer which owuld require immediate treatment
- Another malignancy other than basal cell cancer
- History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists.
- Congenital or acquired coagulation disorders contraindicating intramuscular injections
- Pagets disease of the bone
- QTcB > 450 msec at Day - 14
About this study
Official title: Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
Read the detailed description
Inclusion Criteria
- Males over 18 with documented advanced or metastatic prostate cancer
Outcome measures
- Comparative castration rates one week after starting therapy
- Degree of testosterone surge in the first month of treatment.
- Maintenance of medical castration during one year of therapy.
- Comparison of the treatments on QTc prolongation
- Conditions
- Prostate Cancer
- Being tested
- Abarelix, Goserelin plus Bicalutamide
- Keywords
- Prostate cancer, Advanced, Metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbarelixDrug
Also called Plenaxis
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
Goserelin plus BicalutamideDrug
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
| Study group | Role | What they receive |
|---|---|---|
| 1 Abarelix | Experimental | Investigative drug Receives: Drug: Abarelix |
| 2 Goserelin plus bicalutamide | Active comparator | Standard therapy Receives: Drug: Goserelin plus Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early castration rates
Measured: One week
Secondary outcomes (1)
Maintenance of medical castration
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 1999
- Primary completionFeb 2001
- Study completionFeb 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Speciality European Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frans M J Debruyne, MD, Principal investigator, University Hospital Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841113
- Sponsor's protocol ID
- ABACAS1
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.
- ClinicalTrials.gov ID
- NCT00841113
- Acronym / sponsor ID
- ABACAS1
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Advanced, Metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Speciality European Pharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Feb 2001 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 11 Feb 2009 (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.
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
Detailed description
Inclusion Criteria
- Males over 18 with documented advanced or metastatic prostate cancer
Outcome measures
- Comparative castration rates one week after starting therapy
- Degree of testosterone surge in the first month of treatment.
- Maintenance of medical castration during one year of therapy.
- Comparison of the treatments on QTc prolongation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Abarelix | Experimental | Drug: AbarelixInvestigative drug |
| 2 Goserelin plus bicalutamide | Active comparator | Drug: Goserelin plus BicalutamideStandard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven prostate cancer and not previously treated with hormones
- Evidance of advanced disease or metastases
- Life expentancy of at least 3 months
- Normal serum testosterone levels
- Written informed consent
Key exclusion criteria (7 listed)
- Previous endocrine or cytoxic theapy for prostate cancer
- Known tumour complication of prostate cancer which owuld require immediate treatment
- Another malignancy other than basal cell cancer
- History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists.
- Congenital or acquired coagulation disorders contraindicating intramuscular injections
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 |
|---|---|---|
| AbarelixAlso: Plenaxis100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter | Drug | 1 Abarelix |
| Goserelin plus BicalutamideGoserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months | Drug | 2 Goserelin plus bicalutamide |
Primary outcome
Early castration rates
Time frame: One week
1 secondary outcome
Maintenance of medical castration
Time frame: 48 weeks
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 11 Feb 2009.
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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.
Frans M J Debruyne, MD principal investigator
University Hospital Nijmegen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abarelix and Goserelin plus Bicalutamide in people with Prostate Cancer, run by Speciality European Pharma Limited.
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 5 inclusion and 7 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 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Early castration rates (time frame: One week). 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 11 Feb 2009.