NCT01834209

Brief 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 available for this indication through local healthcare providers, and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

First QC Date

April 15, 2013

Last Update Submit

November 5, 2018

Conditions

Prostate Neoplasms

Keywords

Prostate neoplasmsProstate cancerMetastatic prostate cancerMetatatic castration resistant prostate cancerAbiraterone acetatePrednisonePrednisoloneEarly access program

Interventions

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Brasília, Brazil

Location

Unknown Facility

Florianópolis, Brazil

Location

Unknown Facility

Fortaleza, Brazil

Location

Unknown Facility

Jaú, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Santo André, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone AcetatePrednisonePrednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanesPregnadienetriols

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 17, 2013

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

BR(8)