This trial is active, not recruiting.

Condition prostate cancer
Treatments placebo and prednisone, abiraterone acetate and prednisone
Phase phase 3
Sponsor Janssen Research & Development, LLC
Start date March 2012
End date December 2016
Trial size 313 participants
Trial identifier NCT01591122, ABI-PRO-3002, CR100011


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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
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.

Primary Outcomes

Time to prostate specific antigen (PSA) progression (TTPP)
time frame: 14 months

Secondary Outcomes

Overall survival
time frame: 5 years
Time to initiation of cytotoxic chemotherapy
time frame: 5 years
Prostate specific antigen (PSA) response rate
time frame: 14 months
Objective response rate
time frame: 14 months
Quality of life (QoL) total score and each subscale score
time frame: 14 months
Time to pain progression
time frame: 14 months
Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination
time frame: 14 months
Collection of safety data including adverse events
time frame: 5 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.