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

NCT ID: NCT01591122

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-27
• Study Completion Date: 2019-01-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Abiraterone acetate and prednisone

Group Type: EXPERIMENTAL

Abiraterone acetate and prednisone

Intervention Type: DRUG

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

Placebo and prednisone

Group Type: ACTIVE_COMPARATOR

Placebo and prednisone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Beijing, , China

Chengdu, , China

Chongqing, , China

Guangzhou, , China

Hangzhou, , China

Jinan, , China

Nanjing, , China

Shanghai, , China

Tianjin, , China

Wuhan, , China

Kuala Lumpur, , Malaysia

Arkhangelsk, , Russia

Moscow, , Russia

Pyatigorsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Sochi, , Russia

Stavropol, , Russia

Ufa, , Russia

Yekaterinburg, , Russia

Yoshkar-Ola, , Russia

Bangkok, , Thailand

Countries

China; Malaysia; Russia; Thailand

Related Links

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=

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

Other Identifiers

ABI-PRO-3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR100011

Identifier Type: -

Identifier Source: org_study_id