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A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

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A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer

NCT01834209•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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)
+7 more criteria

Locations (8)

Belo Horizonte, Brazil

Brasília, Brazil

Florianópolis, Brazil

Fortaleza, Brazil

Jaú, Brazil

Porto Alegre, Brazil

Santo André, Brazil

São Paulo, Brazil

Key Dates

Last Updated

November 7, 2018

Conditions

Prostate Neoplasms

Interventions

Abiraterone acetate

DRUG

Prednisone or prednisolone

DRUG

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

NCT03181867

Prostate NeoplasmsProstatic Cancer+3 more

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TERMINATEDNA

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NCT00999960

Prostatic NeoplasmsCancer of Prostate+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

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