Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Conditions
Brief summary
Radiographic progression-free survival, defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) or death due to any cause.
Detailed description
Overall Survival, defined as the time from the date of randomisation until death due to any cause., Time to Second Progression or Death (PFS2), defined as the time from randomisation to the earliest progression after initiation of first subsequent treatment following the initial investigator-assessed progression or death., Time to First Subsequent Therapy or Death (TFST), defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause., Symptomatic Skeletal Event-free Survival., Time to Castration-Resistance (TTCR), defined as the time from randomisation to the first castration-resistant event., Clinical Outcome Assessments, including TTPP, TTDUS, TTDF, TTDPF, and HRQoL.
Interventions
DRUGBAY 1841788
DRUGSaruparib
DRUGAbiraterone Teva 500 mg film-coated tablets
DRUGPlacebo to match (PTM) tablets
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival, defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, defined as the time from the date of randomisation until death due to any cause., Time to Second Progression or Death (PFS2), defined as the time from randomisation to the earliest progression after initiation of first subsequent treatment following the initial investigator-assessed progression or death., Time to First Subsequent Therapy or Death (TFST), defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause., Symptomatic Skeletal Event-free Survival., Time to Castration-Resistance (TTCR), defined as the time from randomisation to the first castration-resistant event., Clinical Outcome Assessments, including TTPP, TTDUS, TTDF, TTDPF, and HRQoL. | — |
Countries
Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed