Prostate Cancer
Conditions
Keywords
Prostate Cancer, Metastatic-castration resistant prostate cancer, Prostate specific antigen, Abiraterone acetate, JNJ-212082, Abiraterone, Prednisolone, Androgen Deprivation, Docetaxel-based chemotherapy
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.
Interventions
DRUGAbiraterone acetate
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.
DRUGPrednisolone
Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Prostate-specific Antigen (PSA) Response | Baseline, Month 4 | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to PSA Progression | Up to 28 Months | 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 | Up to 3 Years | 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. |
| Overall Survival | Up to 3 Years | Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason. |
| Dehydroepiandrosterone Sulfate (DHEA-S) | Baseline and End-of-Treatment Visit (up to approximately 3 years) | 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) | Up to 3 Years | 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. |
| Serum Testosterone | Baseline and End-of-Treatment Visit (up to approximately 3 years) | Median serum testosterone concentration was reported at baseline and End-of-Treatment visit. |
Countries
South Korea, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abiraterone Acetate Abiraterone acetate 1,000 milligram (mg) (administered as 4 \* 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity. | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 1 |
| Overall Study | Noncompliance with Study Drug | 1 |
| Overall Study | Other | 7 |
| Overall Study | Physician Decision | 13 |
| Overall Study | Progressive Disease | 32 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | Abiraterone Acetate |
|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 7.35 |
| Region of Enrollment Korea, Republic Of | 52 Participants |
| Region of Enrollment Taiwan, Province Of China | 30 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 73 / 82 |
| serious Total, serious adverse events | 40 / 82 |
Outcome results
Primary
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: Baseline, Month 4
Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abiraterone Acetate and Prednisolone | Percentage of Participants With Prostate-specific Antigen (PSA) Response | 42.7 Percentage of participants |
Secondary
Dehydroepiandrosterone Sulfate (DHEA-S)
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)
Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Abiraterone Acetate and Prednisolone | Dehydroepiandrosterone Sulfate (DHEA-S) | Baseline | 0.725 micromole per liter |
| Abiraterone Acetate and Prednisolone | Dehydroepiandrosterone Sulfate (DHEA-S) | End-of-Treatment Visit | 0.080 micromole per liter |
Secondary
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.
Time frame: Up to 3 Years
Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abiraterone Acetate and Prednisolone | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 81 Participants |
| Abiraterone Acetate and Prednisolone | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 40 Participants |
Secondary
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 frame: Up to 3 Years
Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate and Prednisolone | Overall Survival | 538 Days |
Secondary
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.
Time frame: Up to 3 Years
Population: Radiographic response-evaluable population included all participants who received at least 1 dose of abiraterone acetate, and had baseline and at least 1 on treatment tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abiraterone Acetate and Prednisolone | Percentage of Participants With Objective Radiographic Response | 6.1 Percentage of participants |
Secondary
Serum Testosterone
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)
Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Abiraterone Acetate and Prednisolone | Serum Testosterone | Baseline | 1.210 nanomole per liter |
| Abiraterone Acetate and Prednisolone | Serum Testosterone | End-of-Treatment Visit | 1.210 nanomole per liter |
Secondary
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.
Time frame: Up to 28 Months
Population: Analysis population included all participants who received at least 1 dose of abiraterone acetate.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abiraterone Acetate and Prednisolone | Time to PSA Progression | 141 Days |