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Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruitingn/aAges 18 Years - anyMaleLithuanian University of Health Sciences
NCT07863986 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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)
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What it tests

  • [177Lu]Lu-PSMA-617 (Pluvicto, Novartis)
  • 68Ga-PSMA-11 PET/CT
  • Post-therapy 177Lu-PSMA SPECT/CT dosimetry
  • Circulating tumor DNA (ctDNA) quantification
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Where

1 site
Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Nuclear Medicine
Kaunas, Lithuania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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