Metastatic Castration-resistant Prostate CancerPhase 3NCT01517802
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
A Phase 3 study testing Abiraterone acetate and Prednisone in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Breast Cancer, run by Janssen Research & Development, LLC at 22 sites in 7 countries.
Trial summary
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, Metastatic Breast Cancer
- What is being tested?
- Abiraterone acetate and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 28 Mar 2012to 22 Apr 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.
Who cannot join
- Medical conditions that require hospitalization.
- Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States10 sites
Study site
Aurora, Colorado
Study site
Boston, Massachusetts
Study site
Chattanooga, Tennessee
Study site
Dallas, Texas
Study site
East Setauket, New York
Study site
Houston, Texas
Study site
Marrero, Louisiana
Study site
Myrtle Beach, South Carolina
Study site
New York, New York
Study site
Omaha, Nebraska
Australia4 sites
Study site
Kogarah
Study site
Kurralta Park
Study site
South Brisbane
Study site
Subiaco
United Kingdom4 sites
Study site
Newcastle upon Tyne
Study site
Northwood
Study site
Sutton
Study site
Whitchurch
About this study
Official title: A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.
Read the detailed description
This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. This study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.
- Being tested
- Abiraterone acetate, Prednisone
- Keywords
- Metastatic castration-resistant prostate cancer, Metastatic breast cancer, Abiraterone acetate, Low-dose corticosteroid treatment, Long-term access
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetateDrug
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
PrednisoneDrug
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate | Experimental | Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study. Receives: Drug: Abiraterone acetate; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Measured: Up to 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start28 Mar 2012
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517802
- Sponsor's protocol ID
- CR100797
- Other IDs
- 212082PCR3010, 2011-005243-28
- Status last verified
- Apr 2022
- First submitted
- 23 Jan 2012
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
- ClinicalTrials.gov ID
- NCT01517802
- Acronym / sponsor ID
- CR100797
- Keywords
- Metastatic castration-resistant prostate cancer, Metastatic breast cancer, Abiraterone acetate, Low-dose corticosteroid treatment, Long-term access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2012 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.
Detailed description
This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. This study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate | Experimental | Drug: Abiraterone acetate, Drug: PrednisonePatients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.
Key exclusion criteria (2 listed)
- Medical conditions that require hospitalization.
- Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
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 |
|---|---|---|
| Abiraterone acetateType=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily | Drug | Abiraterone acetate |
| PrednisoneType=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily | Drug | Abiraterone acetate |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 9 years
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Pluvicto Real-world Investigation in Survival in Metastatic CRPC
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abiraterone acetate and Prednisone in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Breast Cancer, run by Janssen Research & Development, LLC at 22 sites in 7 countries.
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 1 inclusion and 2 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia, United Kingdom, Belgium, Germany and 2 more countries. 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 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?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Serious Adverse Events (SAEs) (time frame: Up to 9 years). 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 10 May 2022.