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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Placebo and prednisone

Drug: Abiraterone acetate and prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01591122

ABI-PRO-3002 (Other Identifier)

CR100011

Details and patient eligibility

About

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).

Full 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.

Enrollment

313 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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