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

Condition(s) targeted: Prostate Cancer

Intervention: abiraterone acetate (Drug); prednisolone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

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.

Official title: A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Prostate specific antigen (PSA) response rate

Secondary outcome:

Overall survival

Time to PSA progression

Objective radiographic response rate (RAD-ORR)

Serum testosterone and dehydroepiandrosterone (DHEA) sulfate

Number of patients with adverse events

Detailed description: This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Busan, Korea, Republic of

Cheongju-Si, Korea, Republic of

Seongnam, Korea, Republic of

Seoul, Korea, Republic of

Kaohsiung, Taiwan

Taichung City, Taiwan

Taichung, Taiwan

Taipei, Taiwan

Taoyuan County, Taiwan

Starting date: August 2011
Last updated: July 27, 2015