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

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

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).

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Abiraterone acetate and prednisone; Drug: Placebo and prednisone

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 Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Chengdu, China
  • Chongqing, China
  • Guangzhou, China
  • Hangzhou, China
  • Jinan, China
  • Nanjing, China
  • Shanghai, China
  • Tianjin, China
  • Wuhan, China
• Malaysia
  • Kuala Lumpur, Malaysia
  • Kuala Lumpur N/a, Malaysia
• Russian Federation
  • Arkhangelsk, Russian Federation
  • Ekaterinburg, Russian Federation
  • Moscow, Russian Federation
  • Moscow N/a, Russian Federation
  • Pyatigorsk, Russian Federation
  • Rostov-on-Don, Russian Federation
  • Sochi, Russian Federation
  • St.-Petersburg, Russian Federation
  • Stavropol, Russian Federation
  • Ufa, Russian Federation
  • Yoshkar-Ola, Russian Federation
• Thailand
  • Bangkok, Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The percentage of people in a study or treatment group who are alive from date of randomization to date of death	5 years
Time to initiation of cytotoxic chemotherapy	Date of randomization to date of initiation of chemotherapy	5 years
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	14 months
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	14 months
Quality of life (QoL) total score and each subscale score	Assessed by functional assessment of cancer therapy-prostate (FACT-P)	14 months
Time to pain progression	Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score	14 months
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)	14 months
Collection of safety data including adverse events		5 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• 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 record dates

Study Major Dates

• Study Start (Actual): March 27, 2012
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer; Abiraterone acetate; Prednisone; Metastatic Castration Resistant Prostate Cancer; Zytiga
• 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; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: CR100011; ABI-PRO-3002 (Other Identifier: Janssen Research & Development, LLC)