Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

• •1. Ability to understand and willingness to sign a written informed consent document.
• •2. Age 21 and older
• •3. Confirmed unresectable PC that is refractory to or has progressed following prior treatments.
• •4. Confirmed unresectable PC with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis)
• •5. Patients must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
• •6. Eastern Cooperative Oncology Group Performance Status ≤ 3
• •7. Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-PSMA PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-PSMA study and completion of the scan
• •8. Patients must be 68Ga-PSMA PET/CT scan positive.
• •9. Hematologic parameters defined as:
• •Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL
• •Blood chemistry levels defined as:
• •AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan