Observes patients with advanced prostate cancer treated with lutetium-177 therapy
Follows men with advanced prostate cancer receiving lutetium-177 PSMA treatment in Finland.
Plain-language title generated from the registry record
Registry title: Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Key facts
- Where
- Kuopio, FinlandSee the site
Where in Finland
- Kuopio University HospitalKuopio, FinlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kuopio University Hospital
- Trial code
- NCT06850545
- Record updated
- 27 February 2025
- Original description
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.Read full original descriptionShow less
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
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.
Inclusion: The patient must sign informed consent to participate in the study; Patients must be over 18 years of age; Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma; 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; Patients must have an adequate performance status: WHO 0-2; 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); Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging; Patients must have adequate renal and liver function (Creatinine < 2x upper limit of normal (ULN), ALT and ALP < 5x ULN); 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); The expected survival must be more than 6 months; Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.
Exclusion: Patients whose physical condition and cooperation are insufficient to follow the given instructions; Patients must not have a recurrent infection that impairs functional capacity; Patients who do not meet the criteria mentioned in the inclusion criteria; 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; Patients with symptomatic untreated spinal cord compression; Patients must not have acute hydronephrosis or urinary tract obstruction.