Clinical trial NCT01685983: A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Metastatic-castration resistant prostate cancer
Prostate specific antigen
Abiraterone acetate
JNJ-212082
Abiraterone
Prednisolone
Androgen Deprivation
Docetaxel-based chemotherapy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-09-17
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Prostate-specific Antigen (PSA) Response
timeFrame: Baseline, Month 4
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 3 Years
measure: Time to PSA Progression
timeFrame: Up to 28 Months
measure: Percentage of Participants With Objective Radiographic Response
timeFrame: Up to 3 Years
measure: Serum Testosterone
timeFrame: Baseline and End-of-Treatment Visit (up to approximately 3 years)
measure: Dehydroepiandrosterone Sulfate (DHEA-S)
timeFrame: Baseline and End-of-Treatment Visit (up to approximately 3 years)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Cheongju-Si
country: Korea, Republic of
city: Seongnam-Si, Gyeonggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kaohsiung
country: Taiwan
city: Taichung City
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan County
country: Taiwan
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: