Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Study Details
This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).
Protocol Summary
Dose exploration only: Number of participants who experience dose limiting toxicities (DLTs)
Timeframe: Up to 3 years
Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Timeframe: Up to 3 years
Number of participants who experience one or more treatment-related adverse events
Timeframe: Up to 3 years
Number of participants who experience a clinically significant change in vital signs
Timeframe: Up to 3 years
Number of participants who experience a clinically significant change in clinical laboratory tests
Timeframe: Up to 3 years
Objective response rate per response evaluation criteria in solid tumors (RECIST) 1.1 with prostate cancer working group 3 (PCWG3) modifications
Timeframe: Up to 3 years
Number of participants who experience circulating tumor cell (CTC) response
Timeframe: Up to 3 years
Number of participants who experience prostate-specific antigen (PSA) response rate
Timeframe: Up to 3 years
Duration of response
Timeframe: Up to 3 years
Overall survival (OS)
Timeframe: Up to 3 years
Progression-free survival
Timeframe: Up to 3 years
Time to progression
Timeframe: Up to 3 years
Time to subsequent therapy
Timeframe: Up to 3 years
Maximum plasma concentration (Cmax)
Timeframe: Up to 3 years
Minimum plasma concentration (Cmin)
Timeframe: Up to 3 years
Area under the concentration-time curve (AUC)
Timeframe: Up to 3 years
Accumulation ratio based on area under the concentration-time curve (AUC)
Timeframe: Up to 3 years
Half-life (t1/2)
Timeframe: Up to 3 years
Change from baseline in prostate-specific membrane antigen (PSMA)-positive tumor burden assessed using gallium (GA) 68-labelled PSMA-11 positron emission tomography/computed tomography (PET/CT)
Timeframe: Baseline up to 3 years
Change from baseline in prostate-specific membrane antigen (PSMA)-negative disease burden assessed using 18F-fluorodeoxyglucose (F-FDG) positron emission tomography/computed tomography (PET/CT)
Timeframe: Baseline to 3 years
Time to symptomatic skeletal events
Timeframe: Up to 3 years
Concentration of alkaline phosphatase
Timeframe: Up to 3 years
Concentration of lactate dehydrogenase (LDH)
Timeframe: Up to 3 years
Concentration of hemoglobin
Timeframe: Up to 3 years
Neutrophil-to-lymphocyte ratio
Timeframe: Up to 3 years
Concentration of N-telopeptide in the urine
Timeframe: Up to 3 years