Prostate NeoplasmsNCT01834209
A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
A study testing Abiraterone acetate and Prednisone or prednisolone in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 8 sites in Brazil.
Trial summary
The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasms
- What is being tested?
- Abiraterone acetate and Prednisone or prednisolone
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 8 sitesBrazil
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Not have received cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer
- Have prostate cancer progression as assessed by the investigator with prostate-specific antigen progression according to Prostate Cancer Working Group 2 criteria
- Have asymptomatic or mildly symptomatic prostate cancer
- Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
- Have Eastern Cooperative Oncology Group performance status of <=2
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- Laboratory values within protocol-defined parameters
- Adequate liver function according to protocol-defined parameters
- Be able to swallow the study drug whole as a tablet
- Agrees to protocol-defined use of effective contraception
Who cannot join
- Eligible for another study of abiraterone acetate that is open to enrollment
- Has received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or COU-AA-302
- Has serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Has uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg); individuals with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
- Has active or symptomatic viral hepatitis or chronic liver disease
- Has a history of pituitary or adrenal dysfunction
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- Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease or left ventricular ejection fraction of <50% at baseline
- Has atrial fibrillation or other cardiac arrhythmia
- Has known brain metastasis
- Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of castration-resistant prostate cancer (CRPC)
- Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
- Has an active infection or other medical condition that would make prednisone/prednisolone use contraindicated
- Has had other anticancer therapy including cytotoxic, radionucleotide, and immunotherapy
- Has had prior systemic treatment with an azole drug; diethylstilbestrol; PC-SPES; spironolactone; and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
- Is currently enrolled in an investigational drug or device study or has participated in such a study within 30 days of Day 1
- Has a condition or situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study
- Has partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Study site
Belo Horizonte
Study site
Brasília
Study site
Florianópolis
Study site
Fortaleza
Study site
Jaú
Study site
Porto Alegre
Study site
Santo André
Study site
São Paulo
About this study
Official title: Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.
Read the detailed description
This is an open-label (identity of assigned study drug will be known) early access protocol (EAP). Approximately 60 participants will be enrolled in this study. Participants will receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily. Treatment in 28-day cycles will continue until progression of clinical disease. Study drug will be provided until the company obtains market authorization and reimbursement in the participant countries for this indication.
- Conditions
- Prostate Neoplasms
- Being tested
- Abiraterone acetate, Prednisone or prednisolone
- Keywords
- Prostate neoplasms, Prostate cancer, Metastatic prostate cancer, Metatatic castration resistant prostate cancer, Abiraterone acetate, Prednisone, Prednisolone, Early access program
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetateDrug
Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily for 28-day cycles
Prednisone or prednisoloneDrug
5 mg tablet taken orally once daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmsStudies 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
- Expanded access
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
- NCT01834209
- Sponsor's protocol ID
- CR100946
- Other IDs
- 212082PCR3012
- Status last verified
- Nov 2018
- First submitted
- 15 Apr 2013
- Last updated
- 7 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01834209
- Acronym / sponsor ID
- CR100946
- Conditions
- Prostate Neoplasms
- Keywords
- Prostate neoplasms, Prostate cancer, Metastatic prostate cancer, Metatatic castration resistant prostate cancer, Abiraterone acetate, Prednisone, Prednisolone, Early access program
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 17 Apr 2013 (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 purpose of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone or prednisolone among adult participants with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) who reside in areas in which abiraterone acetate is not yet available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.
Detailed description
This is an open-label (identity of assigned study drug will be known) early access protocol (EAP). Approximately 60 participants will be enrolled in this study. Participants will receive abiraterone acetate 1000 mg daily plus prednisone or prednisolone 5 mg daily. Treatment in 28-day cycles will continue until progression of clinical disease. Study drug will be provided until the company obtains market authorization and reimbursement in the participant countries for this indication.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Not have received cytotoxic chemotherapy regimens for metastatic castration-resistant prostate cancer
- Have prostate cancer progression as assessed by the investigator with prostate-specific antigen progression according to Prostate Cancer Working Group 2 criteria
- Have asymptomatic or mildly symptomatic prostate cancer
- Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Key exclusion criteria (17 listed)
- Eligible for another study of abiraterone acetate that is open to enrollment
- Has received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or COU-AA-302
- Has serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Has uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg); individuals with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
- Has active or symptomatic viral hepatitis or chronic liver disease
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 acetateAbiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily for 28-day cycles | Drug | – |
| Prednisone or prednisolone5 mg tablet taken orally once daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Open-label Study of Abiraterone Acetate plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects with Metastatic Castration-Resistant Prostate Cancer (Early Access Protocol)Link provided by the sponsor.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abiraterone acetate and Prednisone or prednisolone in people with Prostate Neoplasms, run by Janssen Research & Development, LLC at 8 sites in Brazil.
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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. 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.
Are results available for this study?
Results are not available in the source record.
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.
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 7 Nov 2018.