Metastatic castration resistant prostate cancer
Conditions
Brief summary
Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) mutation-positive participants, OS in AR LBD mutation-negative participants
Detailed description
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD mutation-positive participants, rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD mutation-negative participants, Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review, Duration of Response (DOR) Per PCWG-modified RECIST 1.1 as Assessed by Blinded Independent Central Review, Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score), Time to Prostate-specific Antigen (PSA) Progression, Time to First Symptomatic Skeletal-related Event (SSRE), Number of Participants Who Experience an Adverse Event, Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) mutation-positive participants, OS in AR LBD mutation-negative participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD mutation-positive participants, rPFS Per Prostate Cancer Working Group-modified RECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD mutation-negative participants, Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST), Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review, Duration of Response (DOR) Per PCWG-modified RECIST 1.1 as Assessed by Blinded Independent Central Review, Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score), Time to Prostate-sp | — |
Countries
Austria, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden