NCT07863986 Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
| NCT ID | NCT07863986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lithuanian University of Health Sciences |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-08-04 |
| Primary Completion | 2031-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2026-08-04 with a primary completion date of 2031-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Contraindications to \[177Lu\]Lu-PSMA-617 (Pluvicto) therapy according to the Summary of Product Characteristics * 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) * Another active malignancy (except non-melanoma skin cancer or a clinically insignificant tumor) that could affect the assessment of survival * Refusal to participate in the study (for the prospective part: informed consent not signed)
Frequently Asked Questions
Who can join the NCT07863986 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07863986 currently recruiting?
Yes, NCT07863986 is actively recruiting participants. Visit ClinicalTrials.gov or contact Lithuanian University of Health Sciences to inquire about joining.
Where is the NCT07863986 trial being conducted?
This trial is being conducted at Kaunas, Lithuania.
Who is sponsoring the NCT07863986 clinical trial?
NCT07863986 is sponsored by Lithuanian University of Health Sciences. The trial plans to enroll 70 participants.
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