Back to resultsA Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abiraterone acetate
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Metastatic-castration resistant prostate cancer, Prostate specific antigen, Abiraterone acetate, JNJ-212082, Abiraterone, Prednisolone, Androgen Deprivation, Docetaxel-based chemotherapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abiraterone actetate and Prednisolone
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Serum Testosterone
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
Dehydroepiandrosterone Sulfate (DHEA-S)
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
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.
Full Information
NCT ID
NCT01685983
First Posted
September 12, 2012
Last Updated
February 28, 2019
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01685983
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 30, 2011 (Actual)
Primary Completion Date
January 24, 2013 (Actual)
Study Completion Date
March 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Metastatic-castration resistant prostate cancer, Prostate specific antigen, Abiraterone acetate, JNJ-212082, Abiraterone, Prednisolone, Androgen Deprivation, Docetaxel-based chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abiraterone actetate and Prednisolone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate
Other Intervention Name(s)
JNJ-212082
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
Primary Outcome Measure Information:
Title
Percentage of Participants With Prostate-specific Antigen (PSA) Response
Description
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
Baseline, Month 4
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.
Time Frame
Up to 3 Years
Title
Time to PSA Progression
Description
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.
Time Frame
Up to 28 Months
Title
Percentage of Participants With Objective Radiographic Response
Description
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.
Time Frame
Up to 3 Years
Title
Serum Testosterone
Description
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.
Time Frame
Baseline and End-of-Treatment Visit (up to approximately 3 years)
Title
Dehydroepiandrosterone Sulfate (DHEA-S)
Description
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.
Time Frame
Baseline and End-of-Treatment Visit (up to approximately 3 years)
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 3 Years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Learn more about this trial
A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
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