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Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo and prednisone
Abiraterone acetate and prednisone
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Metastatic Castration Resistant Prostate Cancer, Abiraterone acetate, Prednisone, Zytiga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease
  • Prostate cancer progression documented by PSA progression or radiographic progression
  • Asymptomatic or mildly symptomatic from prostate cancer
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status score of 0 or 1
  • If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1
  • If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1
  • If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
  • Radiation or radionuclide therapy for treatment of mCRPC
  • Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment
  • History of pituitary or adrenal dysfunction

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abiraterone acetate and prednisone

Placebo and prednisone

Arm Description

Outcomes

Primary Outcome Measures

Time to prostate specific antigen (PSA) progression (TTPP)
Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria

Secondary Outcome Measures

Overall survival
The percentage of people in a study or treatment group who are alive from date of randomization to date of death
Time to initiation of cytotoxic chemotherapy
Date of randomization to date of initiation of chemotherapy
Prostate specific antigen (PSA) response rate
Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria
Objective response rate
Measurable disease based on modified response evaluation criteria in solid tumors (RECIST) criteria and baseline lymph node size must be 2.0 cm to be considered target or evaluable lesion for RECIST criteria
Quality of life (QoL) total score and each subscale score
Assessed by functional assessment of cancer therapy-prostate (FACT-P)
Time to pain progression
Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score
Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination
ECOG performance status score 0 (Fully active, able to carry on all pre-disease performance without restriction) versus 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, eg, light housework, office work)
Collection of safety data including adverse events

Full Information

First Posted
May 2, 2012
Last Updated
January 16, 2020
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01591122
Brief Title
Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer
Official Title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2012 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).
Detailed Description
This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.

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, Abiraterone acetate, Prednisone, Zytiga

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abiraterone acetate and prednisone
Arm Type
Experimental
Arm Title
Placebo and prednisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo and prednisone
Intervention Description
Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate and prednisone
Intervention Description
Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily
Primary Outcome Measure Information:
Title
Time to prostate specific antigen (PSA) progression (TTPP)
Description
Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
The percentage of people in a study or treatment group who are alive from date of randomization to date of death
Time Frame
5 years
Title
Time to initiation of cytotoxic chemotherapy
Description
Date of randomization to date of initiation of chemotherapy
Time Frame
5 years
Title
Prostate specific antigen (PSA) response rate
Description
Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria
Time Frame
14 months
Title
Objective response rate
Description
Measurable disease based on modified response evaluation criteria in solid tumors (RECIST) criteria and baseline lymph node size must be 2.0 cm to be considered target or evaluable lesion for RECIST criteria
Time Frame
14 months
Title
Quality of life (QoL) total score and each subscale score
Description
Assessed by functional assessment of cancer therapy-prostate (FACT-P)
Time Frame
14 months
Title
Time to pain progression
Description
Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score
Time Frame
14 months
Title
Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination
Description
ECOG performance status score 0 (Fully active, able to carry on all pre-disease performance without restriction) versus 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, eg, light housework, office work)
Time Frame
14 months
Title
Collection of safety data including adverse events
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease Prostate cancer progression documented by PSA progression or radiographic progression Asymptomatic or mildly symptomatic from prostate cancer Surgically or medically castrated, with testosterone levels of <50 ng/dL Previous anti-androgen therapy and progression after withdrawal ECOG performance status score of 0 or 1 If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1 If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1 If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days Life expectancy of at least 6 months Exclusion Criteria: Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily Pathological finding consistent with small cell carcinoma of the prostate Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) Radiation or radionuclide therapy for treatment of mCRPC Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment History of pituitary or adrenal dysfunction
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
Beijing
Country
China
City
Chengdu
Country
China
City
Chongqing
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Jinan
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
City
Tianjin
Country
China
City
Wuhan
Country
China
City
Kuala Lumpur N/a
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Arkhangelsk
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Moscow N/a
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Pyatigorsk
Country
Russian Federation
City
Rostov-on-Don
Country
Russian Federation
City
Sochi
Country
Russian Federation
City
St.-Petersburg
Country
Russian Federation
City
Stavropol
Country
Russian Federation
City
Ufa
Country
Russian Federation
City
Yoshkar-Ola
Country
Russian Federation
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CR100011&amp;attachmentIdentifier=1f6dad2c-ce67-418a-b152-d8a1f9847a97&amp;fileName=CR100011_CSR_Synopsis.pdf&amp;versionIdentifier=
Description
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer

Learn more about this trial

Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

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