RecruitingNot ApplicableNCT05613738

177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer

Safety and Dosimetry of 177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer

Sponsor

Peking Union Medical College Hospital

Enrollment

9 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

Summary

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-PSMA-EB-01, a new PSMA-specific radiopharmaceutical, in patients with metastatic castration resistant prostate cancer (mCRPC) who will undergo radioligand therapy (RLT). All patients underwent 68Ga-PSMA and 18F-FDG PET/CT for selection and were randomly divided into three groups of 3 people each.The three groups received an approximately 1.11 GBq (30mCi), 1.85 GBq (50 mCi) and 2.59 GBq (70mCi) of 177Lu-PSMA-EB-01 up to 2 cycles, respectively.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive drug called 177Lu-PSMA-EB-01 — which seeks out and attacks prostate cancer cells — in men whose prostate cancer has spread and is no longer responding to hormone therapy. **You may be eligible if...** - You have metastatic castration-resistant prostate cancer (cancer that has spread and no longer responds to hormone therapy) - A special PET/CT scan has confirmed that your cancer cells have high levels of a protein called PSMA, which the drug targets - Your blood counts, kidney, and liver function are in acceptable ranges **You may NOT be eligible if...** - Your kidney function is too low (creatinine above a certain level) - Your blood counts are too low (low red blood cells, white blood cells, or platelets) - You have significant heart problems 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

DRUG1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01

All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

DRUG1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01

All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

DRUG2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.