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

Study Overview
=================
Brief 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.

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.

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.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Abiraterone acetate
* Drug: Prednisolone


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abiraterone actetate and Prednisolone<br> | Drug: Abiraterone acetate<br>* Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.<br>* Other names: JNJ-212082;Drug: Prednisolone<br>* Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason. | Up to 3 Years | 
| Time to PSA Progression | Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved. | Up to 28 Months | 
| Percentage of Participants With Objective Radiographic Response | Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | Up to 3 Years | 
| Serum Testosterone | Median serum testosterone concentration was reported at baseline and End-of-Treatment visit. | Baseline and End-of-Treatment Visit (up to approximately 3 years) | 
| Dehydroepiandrosterone Sulfate (DHEA-S) | Median DHEA-S concentration was reported at baseline and End-of-Treatment visit. | Baseline and End-of-Treatment Visit (up to approximately 3 years) | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 3 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Metastatic-castration resistant prostate cancer, Prostate specific antigen, Abiraterone acetate, JNJ-212082, Abiraterone, Prednisolone, Androgen Deprivation, Docetaxel-based chemotherapy