TheranosticTrials.org

Clinical Trial · NCT06850545

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

Overview

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.

Sponsor

Turku University Hospital

Contacts

Okko-Sakari Kääriäinen, MD (CONTACT)

okko.kaariainen@pshyvinvointialue.fi

+358447179433

ClinicalTrials.gov

NCT06850545

Drug / Compound

PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

  • 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).
  • 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.
  • The expected survival must be more than 6 months.
  • 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 adequate renal and liver function (Creatinine \< 2x upper limit of normal (ULN), ALT and ALP \< 5x ULN).
  • Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.
  • Patients must have an adequate performance status: WHO 0-2.
  • Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging.

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 must not have acute hydronephrosis or urinary tract obstruction.
  • Patients with symptomatic untreated spinal cord compression.
  • Patients who do not meet the criteria mentioned in the inclusion criteria.