Prostate Cancer
Conditions
Brief summary
• Proportion of ARPI-naïve mCRPC participants with PSA decline ≥ 90% from baseline (Cohort 1), • Rates of no mineralocorticoid toxicity, defined as experiencing neither Grade ≥ 1 hypokalemia nor Grade ≥ 2 hypertension (Cohort 2 safety-run in), • Proportion of mHSPC participants with PSA ≤ 0.2 ng/mL at 8 months (Cohort 2), • dose-limiting toxicities (DLTs), AEs, serious Adverse Events (SAEs), laboratory results (including chemistry, hematology and urinalysis), electrocardiograms (ECGs), vital signs, physical examinations and ECOG performance status scores (Cohort 3)
Detailed description
• Radiographic progression-free survival (rPFS), defined as the time from date of randomization/first dose date until the date of radiological progressive disease (PD) per RECIST v1.1 and PCWG3 as determined by investigator or death from any cause • Prostate-specific antigen (PSA) decline ≥ 50% from baseline • PSA decline ≥ 90% from baseline (Cohorts 2 and 3 only), • PSA undetectable rate (≤ 0.2 ng/mL) (Cohorts 1 and 3 only) • PSA undetectable rate (≤ 0.02 ng/mL) • Time to PSA progression per PCWG3 criteria • Objective response rate per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease • Duration of response per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease, • Best overall response per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease, • AEs, SAEs, laboratory results (including chemistry, hematology, urinalysis • spot urine potassium and creatinine (Cohort 2 only) • ECGs, vital signs, physical examinations and ECOG performance status scores (Cohorts 1 + 2 only), • Testosterone suppression to ≤ 1 ng/dL, or achieves a ≥ 90% reduction from baseline level • Mean testosterone values by time point, Time to pain progression defined using pain scores from the BPI-SF and opiate analgesic use.
Interventions
Sponsors
Astellas Pharma Global Development Inc.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Proportion of ARPI-naïve mCRPC participants with PSA decline ≥ 90% from baseline (Cohort 1), • Rates of no mineralocorticoid toxicity, defined as experiencing neither Grade ≥ 1 hypokalemia nor Grade ≥ 2 hypertension (Cohort 2 safety-run in), • Proportion of mHSPC participants with PSA ≤ 0.2 ng/mL at 8 months (Cohort 2), • dose-limiting toxicities (DLTs), AEs, serious Adverse Events (SAEs), laboratory results (including chemistry, hematology and urinalysis), electrocardiograms (ECGs), vital signs, physical examinations and ECOG performance status scores (Cohort 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Radiographic progression-free survival (rPFS), defined as the time from date of randomization/first dose date until the date of radiological progressive disease (PD) per RECIST v1.1 and PCWG3 as determined by investigator or death from any cause • Prostate-specific antigen (PSA) decline ≥ 50% from baseline • PSA decline ≥ 90% from baseline (Cohorts 2 and 3 only), • PSA undetectable rate (≤ 0.2 ng/mL) (Cohorts 1 and 3 only) • PSA undetectable rate (≤ 0.02 ng/mL) • Time to PSA progression per PCWG3 criteria • Objective response rate per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease • Duration of response per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease, • Best overall response per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease, • AEs, SAEs, laboratory results (including chemistry, hematology, urinalysis • spot urine potassium and creatinine (Cohort 2 only) • ECGs, vital signs, physical examinations and ECOG performance status scores (C | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed