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RECRUITING

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

NCT06850545•Kuopio University Hospital

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.
+5 more criteria

Exclusion Criteria

•1. Patients whose physical condition and cooperation are insufficient to follow the given instructions.

Locations (1)

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Key Dates

Start Date

January 10, 2020

Primary Completion Date

December 31, 2030

Completion Date

December 31, 2035

Last Updated

February 27, 2025

Enrollment

150

ESTIMATED participants

Conditions

Metastatic Prostate AdenocarcinomaPSMA PET-Positive Castration-Resistant Prostate Cancer

Contacts

Okko-Sakari Kääriäinen, MD

CONTACT

+358447179433 okko.kaariainen@pshyvinvointialue.fi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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