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

Phase 1

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: 177Lu-EB-PSMA-617

• Registration Number: NCT03403595
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Study Timeline

• Status Verified: 2017-11
• Study Start: 2017-12-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
177Lu-EB-PSMA-617 dosimetry calculation	177Lu-EB-PSMA-617	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.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 177Lu-EB-PSMA617 in normal organs and metastatic castration-resistant prostate cancer.	1 year	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

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	2 months	Adverse events within 2 months after the injection and scanning of patients will be followed and assessed

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China