- Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
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Progressive disease by one or more of the following criteria: Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL, and/or progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
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Must have received no more than one previous AR-directed therapy.
Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting.
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Must have progressed while on ARAT.
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PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader.
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Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration.
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