AZD2265 compared with Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) - VECTRA-01

Inclusion Criteria

• Inclusion Criteria:
• - ≥ 18 years of age.
• - Diagnosis of adenocarcinoma of prostate.
• - Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
• - Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
• - Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
• - Previously treated with at least 1 taxane-based chemotherapy regimen for
• either metastatic hormone-sensitive prostate cancer or CRPC.
• - Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).
• - Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).
• - ECOG performance status of 0 to 2.
• - Adequate organ and bone marrow function as described in study protocol.
• - Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
• - Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
• Exclusion Criteria:
• - Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
• - Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.
• - Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC.
• - History of another primary malignancy, with exceptions.
• - Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
• - Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
• - Clinically significant ECG abnormalities, with exceptions.