Finding What Predicts Response to Lutetium-177 PSMA Therapy in Advanced Prostate Cancer
Looks at scans and blood tests that may predict response to Pluvicto in prostate cancer.
Plain-language title generated from the registry record
Registry title: Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Key facts
- Where
- Kaunas, LithuaniaSee the site
Where in Lithuania
- Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Nuclear MedicineKaunas, LithuaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lithuanian University of Health Sciences
- Trial code
- NCT07863986
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
Identification of Novel Predictive Factors and Their Significance for Improving Radioligand Therapy Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer
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.
Inclusion: Age 18 years or older; Histologically confirmed prostate adenocarcinoma; Progressive, PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) for which [177Lu]Lu-PSMA-617 (Pluvicto) radioligand therapy has been given or is planned, according to the approved Summary of Product Characteristics (previous treatment with an androgen receptor pathway inhibitor and taxane-based chemotherapy); PSMA positivity confirmed on diagnostic [68Ga]Ga-PSMA-11 PET/CT before the start of treatment, defined as at least one tumor lesion with uptake higher than in normal liver; For the prospective part: signed informed consent. For the retrospective part: ethics committee waiver of the requirement to obtain informed consent.
Exclusion: Contraindications to [177Lu]Lu-PSMA-617 (Pluvicto) therapy according to the Summary of Product Characteristics; Another active malignancy (except non-melanoma skin cancer or a clinically insignificant tumor) that could affect the assessment of survival; No PSMA-positive lesions on diagnostic PSMA PET/CT; Diagnostic PSMA PET/CT not performed with [68Ga]Ga-PSMA-11, or not available for quantitative analysis (original images not saved or not accessible); Refusal to participate in the study (for the prospective part: informed consent not signed).