OncoMatch/Clinical Trials/NCT07863986
Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Official title: Identification of Novel Predictive Factors and Their Significance for Improving Radioligand Therapy Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer
Is NCT07863986 recruiting? Yes, currently enrolling (Oct 2026). Studying [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) for prostate cancer.
Treatment: [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) positive (uptake higher than in normal liver)
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
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: androgen receptor pathway inhibitor
previous treatment with an androgen receptor pathway inhibitor
Must have received: taxane-based chemotherapy
previous treatment with ... taxane-based chemotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07863986 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received androgen receptor pathway inhibitor and taxane-based chemotherapy.
Does this trial require FOLH1?
Yes, FOLH1 positive is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify