- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405858
A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy
December 20, 2018 updated by: Janssen Pharmaceutical K.K.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Asahi, Japan
-
Higashi-Ibaraki, Japan
-
Kanazawa, Japan
-
Kobe, Japan
-
Koshigaya, Japan
-
Kumamoto, Japan
-
Narashino, Japan
-
Okayama, Japan
-
Sagamihara, Japan
-
Sakura, Japan
-
Shinjuku-Ku, Japan
-
Sunto, Japan
-
Yokohama, Japan
-
Yokosuka, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abiraterone Acetate
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.
|
Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.
Other Names:
Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy
Time Frame: up to 2 years
|
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.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of PSA Response
Time Frame: Up to 2 years
|
Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date.
|
Up to 2 years
|
Time to PSA Response
Time Frame: Up to 2 years
|
Time to PSA response is the time from start of treatment to PSA progression.
|
Up to 2 years
|
Percentage of Participants Achieving PSA Response by 24 weeks of Therapy
Time Frame: Up to 2 years
|
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.
|
Up to 2 years
|
PSA-based Progression-free Survival (PSA-PFS)
Time Frame: Time from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years)
|
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 from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years)
|
Maximum Serum PSA Decline Evaluation
Time Frame: Baseline and Day 1 of each cycle up to 2 years
|
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.
|
Baseline and Day 1 of each cycle up to 2 years
|
Percentage of Participants With Radiographic Objective Response Rate (RAD-ORR) in Participants with Measurable Lesions at Baseline
Time Frame: Baseline, Day 1 of Cycle 1, 2,3 and 4 until first documented disease progression or up to 2 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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
|
Baseline, Day 1 of Cycle 1, 2,3 and 4 until first documented disease progression or up to 2 years
|
Radiographic Progression-free Survival (RAD-PFS)
Time Frame: Time from enrollment up to radiographic progression or death, whichever occurs first (up to 2 years)
|
RAD-PFS is defined as the time from enrollment to the occurrence of radiographic progression or death.
|
Time from enrollment up to radiographic progression or death, whichever occurs first (up to 2 years)
|
Time to Next Treatment
Time Frame: up to 2 years
|
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.
|
up to 2 years
|
Overall Survival
Time Frame: Time from enrollment to date of death due to any cause (up to 2 years)
|
Overall survival is defined as the time from enrollment to date of death due to any cause.
|
Time from enrollment to date of death due to any cause (up to 2 years)
|
Brief Pain Inventory - Short Form
Time Frame: Baseline, Day 1 of Cycle 1, 2,3 and 4 up to 2 years
|
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.
|
Baseline, Day 1 of Cycle 1, 2,3 and 4 up to 2 years
|
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: up to 2 years
|
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.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2015
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
March 27, 2015
First Submitted That Met QC Criteria
March 27, 2015
First Posted (Estimate)
April 1, 2015
Study Record Updates
Last Update Posted (Actual)
December 21, 2018
Last Update Submitted That Met QC Criteria
December 20, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisolone
- Abiraterone Acetate
Other Study ID Numbers
- CR106841
- ABI-C-14-JP-001-V03 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Castration-Resistant Prostate Cancer
-
Myovant Sciences GmbHRecruitingMetastatic Castration-Resistant Prostate Cancer | Metastatic Castration-Sensitive Prostate Cancer | Non-Metastatic Castration-Resistant Prostate CancerUnited States
-
Janux TherapeuticsRecruitingProstate Cancer | Metastatic Castration-resistant Prostate Cancer | Castration Resistant Prostatic CancerUnited States, Australia
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Clarus TherapeuticsRecruitingProstate Cancer | Castration-resistant Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
Vadim S KoshkinEli Lilly and Company; Prostate Cancer FoundationActive, not recruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Metastatic Castration-resistant Prostate Cancer | Metastatic Prostate Adenocarcinoma | Metastatic Castration-resistant Prostate CarcinomaUnited States
-
Rohan GarjeJanssen Scientific Affairs, LLCNot yet recruitingCastration-resistant Prostate Cancer | Metastatic Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
BAMF HealthRecruitingMetastatic Castration-resistant Prostate CancerUnited States
-
Massachusetts General HospitalBayerCompletedProstate Cancer | Castration-resistant Prostate Cancer | Castration-resistant Prostate Cancer Metastatic to BoneUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingMetastatic Castration-resistant Prostate CancerChina
-
Hinova Pharmaceuticals Inc.CompletedMetastatic Castration Resistant Prostate CancerChina
Clinical Trials on Abiraterone Acetate
-
Janssen Research & Development, LLCCompleted
-
Cougar Biotechnology, Inc.Completed
-
Cougar Biotechnology, Inc.Completed
-
Cougar Biotechnology, Inc.CompletedProstate NeoplasmsUnited Kingdom, United States
-
Janssen Research & Development, LLCCompletedHealthy ParticipantsUnited States
-
Assistance Publique - Hôpitaux de ParisJanssen, LPCompletedProstate CancerFrance
-
Memorial Sloan Kettering Cancer CenterUniversity of California, Los Angeles; Ferring Pharmaceuticals; Wayne State University and other collaboratorsCompleted
-
Janssen Research & Development, LLCCompleted
-
The Affiliated Hospital of Qingdao UniversityCompletedHealthy VolunteersChina
-
Cougar Biotechnology, Inc.Completed