Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorKuopio University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
mCPRC patients treated with 177LuPSMA-I\&T in Kuopio University Hospital.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall survival
Overall survival in the trial
Time frame
5 yearsSecondary outcomes
1
PSA decrease of 50% or more
PSA decrease of 50% or more within the treatment period
Time frame
36 weeks2
Adverse Events
Treatment-related grade ≥3 and serious adverse events
Time frame
36 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kuopio University Hospital
Lead sponsor
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov