RecruitingPhase 1NCT07096128

A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer


Sponsor

Jinming Zhang

Enrollment

36 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radioactive drug called [177Lu] Lu-PSMA-XT in men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). The drug targets a protein called PSMA found on prostate cancer cells and delivers radiation directly to them. The study aims to see if this new version is safe and effective. **You may be eligible if...** - You are a man between 18 and 80 years old - You have confirmed prostate cancer that has spread and is no longer responding to hormone therapy (castrate-resistant) - Your PSMA PET/CT scan shows the cancer is PSMA-positive - You have received at least one hormonal therapy (such as enzalutamide or abiraterone) - You have received at least one or two prior rounds of taxane-based chemotherapy, or you are unable to receive chemotherapy - You are in good physical health (ECOG 0 or 1) with a life expectancy of more than 6 months **You may NOT be eligible if...** - You have received prior PSMA-targeted radioligand therapy - You have received certain other radioactive treatments (e.g., radium-223) within the past 6 months - You have known other active cancers - You have cancer spread to the brain - You have uncontrolled infections, heart failure, or serious complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[177Lu]Lu-PSMA-XT

\[177Lu\]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.


Locations(3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Mianyang Central Hospital

Beijing, Beijing Municipality, China

The First Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07096128


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