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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03403595
• Other study ID #: PekingUMCH-NM16
• Secondary ID: ZIAEB000073
• Status: Recruiting
• Phase: Phase 1
• First received: January 11, 2018
• Last updated: January 11, 2018
• Start date: December 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2017
• Source: Peking Union Medical College Hospital
• Contact: Jie Zang, MD
• Phone: +86 10 69154196
• Email: 15901495106[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 177Lu-EB-PSMA-617
accepted intravenous injection of 177Lu-EB-PSMA-617 and monitored at 2, 24, 72, 120 and 168 hours post-injection.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events collection	Adverse events within 2 months after the injection and scanning of patients will be followed and assessed	2 months