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Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor: Lithuanian University of Health Sciences
Summary
The goal of this observational study is to learn which factors can predict how well lutetium-177 PSMA therapy works in people with metastatic castration-resistant prostate cancer (mCRPC). This therapy is a radioactive medicine (Pluvicto) given into a vein. The main questions it aims to answer are: * Can scan results, radiation dose measurements, and blood test results predict which participants will have their prostate-specific antigen (PSA) level drop by half or more? * Can the same results predict how long participants live without their cancer getting worse? All participants receive Pluvicto as part of their regular medical care. Taking part in the study does not change their treatment. Participants will: * Receive up to 6 Pluvicto treatments, about every 6 weeks, as part of regular care * Have a PSMA PET/CT scan (an imaging test that shows where the cancer is) before treatment and after the last treatment, as part of regular care * Have 3 SPECT/CT scans after each treatment (at 3 to 4 hours, 24 hours, and 5 days) to measure how much radiation reached the tumors and organs, as part of regular care * Give 1 extra blood sample (10 ml) after each treatment to measure tumor DNA in the blood. It is taken from the same needle stick as routine blood tests. * Fill in a quality of life questionnaire (SF-36) before treatment and after every second treatment, during their hospital stay * Have check-ups every 4 to 6 months after treatment ends Researchers will also use existing medical records of people who started Pluvicto at the hospital before the study began.
Official title: Identification of Novel Predictive Factors and Their Significance for Improving Radioligand Therapy Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
70
Start Date
2026-08-04
Completion Date
2031-08
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
[177Lu]Lu-PSMA-617 (Pluvicto, Novartis)
7400 MBq intravenously every 6 weeks (plus or minus 1 week), up to 6 cycles, given as routine care according to the approved Summary of Product Characteristics, independently of study participation.
68Ga-PSMA-11 PET/CT
Baseline scan before the first cycle and follow-up scan approximately 4 to 8 weeks after the last cycle, performed as routine care. Images are analyzed using a standardized assessment framework, and quantitative PET parameters are recorded.
Post-therapy 177Lu-PSMA SPECT/CT dosimetry
Quantitative SPECT/CT at 3 to 4 hours, 24 hours, and 120 hours after each cycle, performed as routine care. Absorbed doses are calculated for organs at risk and tumor lesions.
Circulating tumor DNA (ctDNA) quantification
Study-specific blood sample (10 ml) collected during the same venipuncture as routine blood tests, 2 to 3 weeks after each cycle.
Locations (1)
Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Nuclear Medicine
Kaunas, Lithuania