High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Conditions
Brief summary
Radiographic progression-free survival (rPFS) assessed by the investigator.
Detailed description
rPFS by blinded, independent, central review (BICR), Clinical PFS (cPFS), Castration-resistant prostate cancer (CRPC)-free survival, Time to symptomatic progression, Time to PSA progression, Time to initiation of new anticancer therapy, Overall survival (OS)., The safety endpoints evaluated will include, but are not limited to, the following: AEs, TEAEs, SAEs, clinical laboratory tests, ECGs, vital signs, and physical examinations., Concentrations of abemaciclib., Time to pain progression, Time to deterioration in HRQoL measured by the FACT-P (Physical Well-Being and PCS scores) and EQ-5D-5L.
Interventions
DRUGVerzenios 50 mg film-coated tablets
DRUGPREDNISOLONE
DRUGPREDNISONE
DRUGABIRATERONE ACETATE
DRUGPlacebo to Match LY2835219 50-mg Tablets
Sponsors
Eli Lilly Cork Limited, Eli Lilly & Co.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival (rPFS) assessed by the investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| rPFS by blinded, independent, central review (BICR), Clinical PFS (cPFS), Castration-resistant prostate cancer (CRPC)-free survival, Time to symptomatic progression, Time to PSA progression, Time to initiation of new anticancer therapy, Overall survival (OS)., The safety endpoints evaluated will include, but are not limited to, the following: AEs, TEAEs, SAEs, clinical laboratory tests, ECGs, vital signs, and physical examinations., Concentrations of abemaciclib., Time to pain progression, Time to deterioration in HRQoL measured by the FACT-P (Physical Well-Being and PCS scores) and EQ-5D-5L. | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed