Back to resultsA Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
Primary Purpose
Metastatic Castration-Resistant Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Abiraterone Acetate
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Cancer focused on measuring Metastatic Castration-Resistant Prostate Cancer, Abiraterone Acetate, ZYTIGA, Prednisolone
Eligibility Criteria
Inclusion Criteria:
- Participants who have histologically or cytologically confirm adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Participants who had prostate-specific antigen (PSA) progression defined as a rise of PSA at least 1 week apart resulting in 25 percent (%) increase in PSA with last PSA greater than (>) 2 nanogram per milliliter (ng/mL) (according to PCWG2) after antiandrogen withdrawal
- Participants who had PSA progression within a year after the start of first-line CAB therapy, or who had PSA progression without having a normal PSA level (less than [<] 4.0 ng/mL) in the first-line combined androgen blockade (CAB) therapy
- Participants who have not been treated with cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer (neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is greater than or equal to [>=] 1 year from the scheduled date of initial administration of abiraterone acetate)
- Participants who have target or non-target metastatic abnormalities either on screening bone scan, computed tomography (CT) or magnetic resonance imaging (MRI)
Exclusion Criteria:
- A participant who has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
- A participant who has severe liver dysfunction (Child-Pugh Score C), active or symptomatic viral hepatitis or chronic liver disease
- A participant who has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels (example: Saw Palmetto and PC-SPES) within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
- A participant who has had surgery or local prostatic intervention within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
- A participant who has active infection or other medical condition that would make prednisolone use contraindicated
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abiraterone Acetate
Arm Description
Participants will receive abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily, concomitantly with oral prednisolone 10 mg per day. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least one hour after the dose of abiraterone acetate is taken. A 28-daily dosing cycle will continue until disease progression or unacceptable toxicity is observed up to 2 years.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy
A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.
Secondary Outcome Measures
Duration of PSA Response
Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date.
Time to PSA Response
Time to PSA response is the time from start of treatment to PSA progression.
Percentage of Participants Achieving PSA Response by 24 weeks of Therapy
A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 24 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.
PSA-based Progression-free Survival (PSA-PFS)
PSA-based Progression-free Survival is the time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death.
Maximum Serum PSA Decline Evaluation
Maximum PSA Decline will be calculated as Baseline PSA level minus lowest PSA level, observed during the 2 year monthly planned PSA lab test and lowest PSA data will be used for calculating the maximum serum PSA decline.
Percentage of Participants With Radiographic Objective Response Rate (RAD-ORR) in Participants with Measurable Lesions at Baseline
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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Radiographic Progression-free Survival (RAD-PFS)
RAD-PFS is defined as the time from enrollment to the occurrence of radiographic progression or death.
Time to Next Treatment
Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.
Overall Survival
Overall survival is defined as the time from enrollment to date of death due to any cause.
Brief Pain Inventory - Short Form
Pain will be evaluated using the BPI-SF instrument. Total score is an average of the pain interference score (mean value for the 9 BPI-SF questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-SF questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Full Information
NCT ID
NCT02405858
First Posted
March 27, 2015
Last Updated
December 20, 2018
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT02405858
Brief Title
A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
Official Title
A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 10, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the percentage of participants achieving prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.
Detailed Description
This is a Phase 4, non-randomized, multi-center (when more than one hospital work on a medical research study), open label (identity of study drug will be known to participant and study staff), single arm study of abiraterone acetate to investigate its efficacy and safety in participants with metastatic castration-resistant prostate cancer (mCRPC) who failed the first-line combined androgen blockade (CAB) therapy. The study consists of Screening Phase (28 days prior to Cycle 1 Day 1), Treatment Phase (up to 2 years), Post Treatment Phase (30 days after the last dose of study drug). Participants will receive 1000 milligram (mg) (four 250 mg tablets) of abiraterone acetate orally once daily. In addition, 5 mg of oral prednisolone will be concomitantly administered twice a day (10 mg per day). A 28-daily dosing cycle will be continued until disease progression or unacceptable toxicity is observed. The total duration of study will be 2 years. Participants will be primarily evaluated for PSA response. Participants' safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-Resistant Prostate Cancer
Keywords
Metastatic Castration-Resistant Prostate Cancer, Abiraterone Acetate, ZYTIGA, Prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abiraterone Acetate
Arm Type
Experimental
Arm Description
Participants will receive abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily, concomitantly with oral prednisolone 10 mg per day. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least one hour after the dose of abiraterone acetate is taken. A 28-daily dosing cycle will continue until disease progression or unacceptable toxicity is observed up to 2 years.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Acetate
Other Intervention Name(s)
ZYTIGA
Intervention Description
Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy
Description
A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Duration of PSA Response
Description
Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date.
Time Frame
Up to 2 years
Title
Time to PSA Response
Description
Time to PSA response is the time from start of treatment to PSA progression.
Time Frame
Up to 2 years
Title
Percentage of Participants Achieving PSA Response by 24 weeks of Therapy
Description
A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 24 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after the initial documentation.
Time Frame
Up to 2 years
Title
PSA-based Progression-free Survival (PSA-PFS)
Description
PSA-based Progression-free Survival is the time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death.
Time Frame
Time from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years)
Title
Maximum Serum PSA Decline Evaluation
Description
Maximum PSA Decline will be calculated as Baseline PSA level minus lowest PSA level, observed during the 2 year monthly planned PSA lab test and lowest PSA data will be used for calculating the maximum serum PSA decline.
Time Frame
Baseline and Day 1 of each cycle up to 2 years
Title
Percentage of Participants With Radiographic Objective Response Rate (RAD-ORR) in Participants with Measurable Lesions at Baseline
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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time Frame
Baseline, Day 1 of Cycle 1, 2,3 and 4 until first documented disease progression or up to 2 years
Title
Radiographic Progression-free Survival (RAD-PFS)
Description
RAD-PFS is defined as the time from enrollment to the occurrence of radiographic progression or death.
Time Frame
Time from enrollment up to radiographic progression or death, whichever occurs first (up to 2 years)
Title
Time to Next Treatment
Description
Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.
Time Frame
up to 2 years
Title
Overall Survival
Description
Overall survival is defined as the time from enrollment to date of death due to any cause.
Time Frame
Time from enrollment to date of death due to any cause (up to 2 years)
Title
Brief Pain Inventory - Short Form
Description
Pain will be evaluated using the BPI-SF instrument. Total score is an average of the pain interference score (mean value for the 9 BPI-SF questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-SF questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.
Time Frame
Baseline, Day 1 of Cycle 1, 2,3 and 4 up to 2 years
Title
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have histologically or cytologically confirm adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
Participants who had prostate-specific antigen (PSA) progression defined as a rise of PSA at least 1 week apart resulting in 25 percent (%) increase in PSA with last PSA greater than (>) 2 nanogram per milliliter (ng/mL) (according to PCWG2) after antiandrogen withdrawal
Participants who had PSA progression within a year after the start of first-line CAB therapy, or who had PSA progression without having a normal PSA level (less than [<] 4.0 ng/mL) in the first-line combined androgen blockade (CAB) therapy
Participants who have not been treated with cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer (neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is greater than or equal to [>=] 1 year from the scheduled date of initial administration of abiraterone acetate)
Participants who have target or non-target metastatic abnormalities either on screening bone scan, computed tomography (CT) or magnetic resonance imaging (MRI)
Exclusion Criteria:
A participant who has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
A participant who has severe liver dysfunction (Child-Pugh Score C), active or symptomatic viral hepatitis or chronic liver disease
A participant who has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels (example: Saw Palmetto and PC-SPES) within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
A participant who has had surgery or local prostatic intervention within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
A participant who has active infection or other medical condition that would make prednisolone use contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Asahi
Country
Japan
City
Higashi-Ibaraki
Country
Japan
City
Kanazawa
Country
Japan
City
Kobe
Country
Japan
City
Koshigaya
Country
Japan
City
Kumamoto
Country
Japan
City
Narashino
Country
Japan
City
Okayama
Country
Japan
City
Sagamihara
Country
Japan
City
Sakura
Country
Japan
City
Shinjuku-Ku
Country
Japan
City
Sunto
Country
Japan
City
Yokohama
Country
Japan
City
Yokosuka
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR106841&attachmentIdentifier=79e26442-4a50-4f25-82f6-4c35ae397eed&fileName=CR106841_CSR.pdf&versionIdentifier=
Description
A Phase 4 Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Patients Who Poorly Responded to the First-line Combined Androgen Blockade Therapy
Learn more about this trial
A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
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