An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

Cougar Biotechnology, Inc.58 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms Prostate Cancer

Interventions

Abiraterone acetateDRUG

Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.

PrednisoneDRUG

Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology * Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel * Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (\>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria * Ongoing androgen deprivation with serum testosterone less than (\<) 50 nanogram per deciliter (ng/dL) * Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (\<=) 2 (Karnofsky Performance Status \>= 50 percent) Exclusion Criteria: * Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Uncontrolled hypertension (high blood pressure) * Hemoglobin \<=9.0 gram per deciliter (g/dL) without growth factor or transfusion support * Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function

Locations (14)

UCLA

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Percentage of Participants With Prostate Specific Antigen (PSA) Response

The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.

Time frame: Day 1 of each cycle (of 28 days each) up to Cycle 12

Secondary Outcomes

Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)

The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group \[PSAWG\] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.

Time frame: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Radiographic Progression Free Survival (PFS)

The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Time frame: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Overall Survival (OS)

Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.

Time frame: Every 3 months until death or up to 60 months

Data from ClinicalTrials.gov

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