177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer

Study Overview
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Brief Summary
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This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-EB-PSMA-617. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617 within one week, then monitored at 2, 24, 72, 120 and 168 h after 177Lu-EB-PSMA617 administration with serial whole body planar and SPECT/CT imaging.

Detailed Description
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Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound, provide an effective target for the treatment of metastatic castration-resistant prostate cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short half-life and fast rate of clearance. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer.

Official Title
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Safety and Dosimetry of 177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer

Conditions
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Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: 177Lu-EB-PSMA-617


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy. Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617. Exclusion Criteria: The exclusion criteria were 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 and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 177Lu-EB-PSMA-617 dosimetry calculation<br>All patients were intravenous injected with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617, then monitored at 2, 24, 72, 120 and 168 hours post-injection. | Drug: 177Lu-EB-PSMA-617<br>* accepted intravenous injection of 177Lu-EB-PSMA-617 and monitored at 2, 24, 72, 120 and 168 hours post-injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 177Lu-EB-PSMA617 in normal organs and metastatic castration-resistant prostate cancer. | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and metastatic castration-resistant prostate cancer will be measured | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed | 2 months |