Clinical trial NCT06850545: Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Official title: Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Prostate Adenocarcinoma
PSMA PET-Positive Castration-Resistant Prostate Cancer
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2025-02-27
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mCPRC patients treated with 177LuPSMA-I\&T in Kuopio University Hospital.

Brief 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 criteria: 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.
11. Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.

Exclusion Criteria:

1. Patients whose physical condition and cooperation are insufficient to follow the given instructions.
2. Patients who do not meet the criteria mentioned in the inclusion criteria.
3. 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.
4. Patients with symptomatic untreated spinal cord compression.
5. Patients must not have acute hydronephrosis or urinary tract obstruction.
6. Patients must not have a recurrent infection that impairs functional capacity.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: PSA decrease of 50% or more
timeFrame: 36 weeks
measure: Adverse Events
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: North Savo
Study officials:
References: