A Phase 3 interventional study of Placebo and prednisone and Abiraterone acetate and prednisone in Prostate Cancer, sponsored by Janssen Research & Development, LLC. Completed at 24 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-21.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
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).
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 313 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Abiraterone acetate 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.
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
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
Time frame: 14 months
Overall survival
The percentage of people in a study or treatment group who are alive from date of randomization to date of death
Time frame: 5 years
Time to initiation of cytotoxic chemotherapy
Date of randomization to date of initiation of chemotherapy
Time frame: 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
Time frame: 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
Time frame: 14 months
Quality of life (QoL) total score and each subscale score
Assessed by functional assessment of cancer therapy-prostate (FACT-P)
Time frame: 14 months
Time to pain progression
Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score
Time frame: 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)
Time frame: 14 months
Collection of safety data including adverse events
Time frame: 5 years
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC