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

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About this study

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.

Condition
Metastatic Prostate Adenocarcinoma, PSMA PET-Positive Castration-Resistant Prostate Cancer
Sponsor
Kuopio University Hospital

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Metastatic Prostate Adenocarcinoma, PSMA PET-Positive Castration-Resistant Prostate Cancer
  • 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 6

  • Patients whose physical condition and cooperation are insufficient to follow the given instructions.
  • 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.
  • Patients must not have a recurrent infection that impairs functional capacity.

Where

1 site, 1 recruiting

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.