Overview

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

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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
Arm
(Experimental)
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

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

Secondary Outcomes

Measure
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 April 2017.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.