Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer (NCT06850545) | Clinical Trial Compass
RecruitingNot Applicable
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Finland150 participantsStarted 2020-01-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Exclusion criteria
. Patients whose physical condition and cooperation are insufficient to follow the given instructions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.