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A Phase 1/2 open-label, multi-center, dose-escalation study of safety, tolerability, pharmacokinetics, dosimetry, and response to repeat dosing of 177Lu-PSMA-R2 radio-ligand therapy in patients with prostate specific membrane antigen (PSMA) positive (68Ga-PSMA-R2) progressive metastatic castration-resistant prostate cancer, following previous systemic treatment.
Ana Ponce Kiess
Johns Hopkins Kimmel Cancer Center in Baltimore
Primary Objective is to characterize the safety profile and tolerability of 177Lu-PSMA-R2 treatment. Secondary Objective is to assess the anti-tumor response based on PSA, time to PSA progression, radiographic progression-free survival, and overall survival.
Patients must have adenocarcinoma of the prostate, metastatic disease documented by CT/MRI or bone scan revealing at least one metastatic lymph-node, visceral metastasis and/or bone metastasis. At least 28 days must have elapsed between last anti-cancer treatment administration and the initiation of study treatment.Prior major surgery must be at least 12 weeks prior to study entry. Patients cannot have a histology different than adenocarcinoma. Patient cannot have prior exposure to radioligand therapy, spinal cord compression or brain metastases, uncontrolled cardiovascular history, or history of deep vein thrombosis and/or pulmonary embolism.
All patients will receive 1-4 cycles of 177Lu-PSMA-R2 administration 6 weeks apart
08/07/2020 05:02 AM