This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Inavolisib will be administered orally as per the schedule specified in the protocol.
Enzalutamide will be administered orally as per the schedule specified in the protocol.
Abiraterone will be administered orally as per the schedule specified in the protocol.
Radiographic Progression-free Survival (rPFS)
Time frame: Up to approximately 5 years
Percentage of Participants with Confirmed Composite Response Rate (RR)
Time frame: Up to approximately 5 years
Percentage of Participants with Confirmed Prostate-Specific Antigen 90 (PSA90)
Time frame: Up to approximately 5 years
Percentage of Participants with Confirmed Prostate-Specific Antigen 50 (PSA50)
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 5 years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 5 years
Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.
CONTACT
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CONTACT
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Docetaxel will be administered intravenously as per the schedule specified in the protocol.
VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS
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