NCT07863986Recruiting
Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Identification of Novel Predictive Factors and Their Significance for Improving Radioligand Therapy Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 4 Aug 2026
- Primary completion date
- Aug 2031
- Lead sponsor
- Lithuanian University of Health Sciences
- Diseases
- Prostate cancer
- NCT number
- NCT07863986
What you commit to
- Study type: Observational
- Planned participants: 70
- From 4 Aug 2026 to the primary completion date, Aug 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to \[177Lu\]Lu-PSMA-617 (Pluvicto) therapy according to the Summary of Product Characteristics
Other illness
- Another active malignancy (except non-melanoma skin cancer or a clinically insignificant tumor) that could affect the assessment of survival
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Nuclear Medicine Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.