Metastatic Castration Resistant Prostate Cancer (mCRPC)
Conditions
Brief summary
Overall survival is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised patients as randomised, regardless of whether the patient withdraws from therapy or receives another anticancer therapy., Radiographic Progression-free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone as Assessed by the Investigator
Detailed description
OS is defined as time from randomisation until the date of death due to any cause., Radiographic Progression-free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone as Assessed by the Investigator, Time to pain progression (TTPP) based on a 2-point increase from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use, Time to start Symptomatic Skeletal-Related Event (SSRE), Time to deterioration in urinary symptoms (TTDUS), change from baseline that reaches a clinically meaningful deterioration threshold., Time to deterioration in Physical Functioning (TTDPF), change from baseline that reaches a clinically meaningful deterioration threshold., Change from baseline in BPI-SF worst pain score, pain severity and interference domain scores., Plasma concentration of capivasertib derived from a population PK model
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised patients as randomised, regardless of whether the patient withdraws from therapy or receives another anticancer therapy., Radiographic Progression-free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone as Assessed by the Investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is defined as time from randomisation until the date of death due to any cause., Radiographic Progression-free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone as Assessed by the Investigator, Time to pain progression (TTPP) based on a 2-point increase from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Item 3 'worst pain in 24 hours' score and/or initiation of/increase in opioid analgesic use, Time to start Symptomatic Skeletal-Related Event (SSRE), Time to deterioration in urinary symptoms (TTDUS), change from baseline that reaches a clinically meaningful deterioration threshold., Time to deterioration in Physical Functioning (TTDPF), change from baseline that reaches a clinically meaningful deterioration threshold., Change from baseline in BPI-SF worst pain score, pain severity and interference domain scores., Plasma concentration of capivasertib derived from | — |
Countries
Belgium, Czechia, France, Greece, Hungary, Netherlands, Poland, Spain
Outcome results
None listed