A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

• Status: Completed
• Trial end date: 2018-03-06
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Androgens; Docetaxel; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)

• Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria

• Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel

• Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL

• Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment

• Eastern Cooperative Oncology Group Performance Status less than or equal to 2

Exclusion Criteria:

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

• Uncontrolled hypertension

• Hemoglobin less than or equal to 9.0 g/dL independent of transfusion

• Has abnormal liver function tests

• Surgery or local prostatic intervention within 30 days of the first dose