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

未提供0 个研究点目标入组 40 人开始时间: 待定

适应症

试验速览

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•18 years of age or more.
•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 Beta-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
•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.

•Prior treatment with an alpha-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
•Progression on PSMA-directed Beta-emitting radioconjugate prior to the administration of Cycle
•Receipt of > 6 cycles of PSMA-directed Beta-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.

发起方

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