OncoMatch/Clinical Trials/NCT04597411
Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer
Is NCT04597411 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for prostatic neoplasms, castration-resistant.
This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of \[225Ac\]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to \[177Lu\]Lu-PSMA-617 (177Lu-PSMA-617) or \[177Lu\]Lu-PSMA I\&T (177Lu-PSMA I\&T).
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 (positive on 68Ga-PSMA-11 PET/CT)
Patients must have a positive 68Ga-PSMA-11 PET/CT scan performed within 28 days of study entry. If a patient also has soft tissue or visceral disease, it must be PSMA-positive on 68Ga-PSMA-11 PET/CT scan.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: Strontium-89
Previous treatment with Strontium-89
Cannot have received: Samarium-153
Previous treatment with Samarium-153
Cannot have received: Rhenium-186
Previous treatment with Rhenium-186
Cannot have received: Rhenium-188
Previous treatment with Rhenium-188
Cannot have received: Radium-223
Previous treatment with Radium-223
Cannot have received: hemi-body irradiation
Previous treatment with hemi-body irradiation
Cannot have received: investigational agents
Any investigational agents within 28 days of study enrollment
Cannot have received: cytotoxic chemotherapy
Exception: other than as specified per cohort
Other concurrent cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy
Cannot have received: targeted therapy
Exception: other than as specified per cohort
Other concurrent cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy
Cannot have received: biologic agents
Exception: other than as specified per cohort
Other concurrent cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy
Cannot have received: immunotherapy
Exception: other than as specified per cohort
Other concurrent cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy
Cannot have received: radioligand therapy
Exception: other than as specified per cohort
Other concurrent cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy
Lab requirements
Blood counts
adequate bone marrow reserve
Kidney function
adequate renal function
Liver function
adequate hepatic function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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