Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer

Inclusion Criteria

• •1. The patient must sign informed consent to participate in the study.
• •2. Patients must be over 18 years of age.
• •3. Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma.
• •4. Patients must have metastatic castration-resistant prostate cancer (mCRPC) that has been treated with at least docetaxel and abiraterone or enzalutamide, or the patients must have declined chemotherapy or be ineligible for docetaxel-based chemotherapy due to contraindications.
• •5. Patients must have an adequate performance status: WHO 0-2.
• •6. Castration must have been achieved either chemically (LHRH analog or antagonist) or surgically (orchiectomy). Castration is defined as a low testosterone level (S-testosterone ≤ 1.7 mmol/l).
• •7. Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging.
• •8. Patients must have adequate renal and liver function (Creatinine \< 2x upper limit of normal (ULN), ALT and ALP \< 5x ULN).
• •9. Patients' blood counts must be within acceptable levels (Hb ≥ 100 g/l, Platelets ≥ 100 x 10⁹/L, Leukocytes ≥ 3.0 x 10⁹/L, or Neutrophils ≥ 1.0 x 10⁹/L).
• •10. The expected survival must be more than 6 months.
• •11. Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.
• •3. Patients must not have PSMA-negative tumor burden in the liver. The amount of PSMA-negative tumor burden must not exceed the amount of PSMA-positive tumor burden.
• •4. Patients with symptomatic untreated spinal cord compression.
• •5. Patients must not have acute hydronephrosis or urinary tract obstruction.
• •6. Patients must not have a recurrent infection that impairs functional capacity.