Metastatic castration-resistant prostate cancer (mCRPC)
Conditions
Brief summary
The primary endpoint is radiographic progression-free survival (rPFS).
Detailed description
Overall survival (OS) is defined as the time from date of randomization to date of death from any cause., Time to chronic opioid use (oral opioid use for ≥3 weeks; parenteral opioid use for ≥7 days) is defined as the time from date of randomization to the first date of opioid use, Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy, Time to pain progression defined as the time from date of randomization to the first date a subject experience an increase by 2 points from baseline in the BPI-SF worst pain intensity item 3 observed at 2 consecutive evaluations ≥4 weeks apart or initiation of chronic opioids, whichever occurs first
Interventions
Sponsors
Janssen Cilag International
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is radiographic progression-free survival (rPFS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) is defined as the time from date of randomization to date of death from any cause., Time to chronic opioid use (oral opioid use for ≥3 weeks; parenteral opioid use for ≥7 days) is defined as the time from date of randomization to the first date of opioid use, Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy, Time to pain progression defined as the time from date of randomization to the first date a subject experience an increase by 2 points from baseline in the BPI-SF worst pain intensity item 3 observed at 2 consecutive evaluations ≥4 weeks apart or initiation of chronic opioids, whichever occurs first | — |
Countries
Germany, Netherlands, Spain
Outcome results
None listed