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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613738
• Other study ID #: PUMCH-NM-PSMAEB01
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: November 15, 2023

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: 86-13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. The investigators designed and synthesized a new radiopharmaceutical, named 177Lu-PSMA-EB-01. EB（Evans Blue）can bind to albumin to slow down its plasma clearance rate, thereby increasing tumor accumulation and reducing the total dosage of Lu-177. Hence, EB-PSMA-01 may be an option for consideration due to limited supply of Lu-177, by which more patients may be benefited by this version of 177Lu-EB-PSMA-01. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-01 in patients with metastatic castration resistant prostate cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: November 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 1.11 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.
• 1.85 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.
• 2.59 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetry of normal organs and tumors	The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-PSMA-EB-01. The dose delivered to normal organs and tumors will be recorded.	through study completion, an average of 4 weeks
Primary	Hematologic adverse events collection	Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0	through study completion, an average of 6 months
Primary	Hepatic and renal toxic events collection	Liver function, and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.	through study completion, an average of 6 months
Secondary	PSA Response	The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-PSMA-EB-01. PSA response was classified as the following: partial response (PR) if PSA decrease =50%, progressive disease (PD) if PSA increase = 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%.	through study completion, an average of 6 months