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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01591122

Collaborator

(none)

313

Enrollment

Locations

Arms

82.2

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Placebo and prednisone Drug: Abiraterone acetate and prednisone	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

313 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 27, 2012

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abiraterone acetate and prednisone	Drug: Abiraterone acetate and prednisone 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
Active Comparator: Placebo and prednisone	Drug: Placebo and prednisone 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.

Arm

Intervention/Treatment

Experimental: Abiraterone acetate and prednisone

Drug: Abiraterone acetate and prednisone

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

Active Comparator: Placebo and prednisone

Drug: Placebo and prednisone

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.

Outcome Measures

Primary Outcome Measures

Time to prostate specific antigen (PSA) progression (TTPP) [14 months]
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 [5 years]
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 [5 years]
Date of randomization to date of initiation of chemotherapy
Prostate specific antigen (PSA) response rate [14 months]
Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria
Objective response rate [14 months]
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 [14 months]
Assessed by functional assessment of cancer therapy-prostate (FACT-P)
Time to pain progression [14 months]
Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score
Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination [14 months]
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 [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	City	Country
1	Beijing	China
2	Chengdu	China
3	Chongqing	China
4	Guangzhou	China
5	Hangzhou	China
6	Jinan	China
7	Nanjing	China
8	Shanghai	China
9	Tianjin	China
10	Wuhan	China
11	Kuala Lumpur N/a	Malaysia
12	Kuala Lumpur	Malaysia
13	Arkhangelsk	Russian Federation
14	Ekaterinburg	Russian Federation
15	Moscow N/a	Russian Federation
16	Moscow	Russian Federation
17	Pyatigorsk	Russian Federation
18	Rostov-on-Don	Russian Federation
19	Sochi	Russian Federation
20	St.-Petersburg	Russian Federation
21	Stavropol	Russian Federation
22	Ufa	Russian Federation
23	Yoshkar-Ola	Russian Federation
24	Bangkok	Thailand