Recruiting NCT06850545
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Prostate Adenocarcinoma, PSMA PET-Positive Castration-Resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Primary outcome measures
- Overall survival [Time frame: 5 years]
Secondary outcome measures (2)
- PSA decrease of 50% or more [Time frame: 36 weeks]
- Adverse Events [Time frame: 36 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Finland · 1 center
- Kuopio University Hospital — Kuopio
Identifiers
NCT: NCT06850545 · KUH5654217