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

Launched by KUOPIO UNIVERSITY HOSPITAL · Feb 22, 2025

Keywords

ClinConnect Summary

The Kuopio Lutetium-177 Study is a clinical trial aimed at understanding the effectiveness and safety of a treatment called 177LuPSMA-I&T for men with advanced prostate cancer that has spread to other parts of the body. This study is being conducted at Kuopio University Hospital in Finland and is currently looking for participants. To be eligible, men must be at least 18 years old, have confirmed metastatic prostate cancer that has not responded to hormone treatments, and have undergone previous chemotherapy. They also need to show signs of cancer on a specific type of imaging test called PSMA PET-CT.

Participants in this study can expect to receive the treatment and be monitored for its effects on their health, including any side effects and how well the treatment works. It’s important to note that men who can still father children will need to agree not to donate sperm during the study and for six months afterward. This trial is a chance to contribute to important research that could help improve treatment options for prostate cancer in the future.

Gender

MALE

Eligibility criteria

• 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.
• Exclusion Criteria:
• • 1. Patients whose physical condition and cooperation are insufficient to follow the given instructions.
• • 2. Patients who do not meet the criteria mentioned in the inclusion criteria.
• • 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.