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Recruiting NCT06850545

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

Trial Parameters

Condition Metastatic Prostate Adenocarcinoma
Sponsor Kuopio University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 150
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2020-01-10
Completion 2030-12-31

Brief Summary

KuPSMALu-trial is an observational study for patients treated with 177LuPSMA-I\&T in Kuopio University Hospital, Finland. Study focuses on efficacy, safety and biomarker research.

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

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