Abbreviations
Lu-PSMA-617
SoC
551
280
Phase:
3
Open label
Prostate
mCRPC
meta
L3
- Patients must have the ability to understand and sign an approved informed consent form (ICF).dc-return- Patients must have the ability to understand and comply with all protocol requirements.dc-return- Patients must be ≥18 years of age.dc-return- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.dc-return- Patients must have a life expectancy >6 months.dc-return- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.dc-return- Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader.dc-return- Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).dc-return- Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).dc-return- Patients must have been previously treated with at least 1, but no more
- Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.dc-return- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization.dc-return- Any investigational agents within 28 days prior to day of randomization.dc-return- Known hypersensitivity to the components of the study therapy or its analogs.dc-return- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.dc-return- Transfusion for the sole purpose of making a subject eligible for study inclusion.dc-return- Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma