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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Nov 6, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called 177Lu-PSMA-EB-01 for men with metastatic castration-resistant prostate cancer (mCRPC), which means their cancer has spread and is no longer responding to standard hormone therapy. The study aims to find out how safe this treatment is and how much of it is absorbed by the body when given during radioligand therapy (RLT). Participants will be divided into three groups, each receiving different doses of the treatment, and they will undergo special imaging tests to help researchers understand how well the treatment works.

To be eligible for this trial, participants must be men aged between 65 and 74 years who have been diagnosed with progressive mCRPC and have tumors that show high levels of a specific protein called PSMA, identified through imaging tests. However, there are some health conditions that would exclude someone from participating, such as certain blood test results or heart problems. Those who join the study can expect to receive this new treatment over two cycles, and they will be closely monitored for safety and effectiveness throughout the trial.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • progressive metastatic castration-resistant prostate cancer
• • tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT
• Exclusion Criteria:
• • a serum creatinine level of more than 150 μmol per liter
• • a hemoglobin level of less than 10.0 g/dl
• • a white-cell count of less than 4.0× 109/L
• • a platelet count of less than 100 × 109/L
• • a total bilirubin level of more than 3 times the upper limit of the normal range
• • a serum albumin level of more than 3.0 g per deciliter
• • cardiac insufficiency