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

Not Applicable

Recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01; Drug: 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01; Drug: 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

• Registration Number: NCT05613738
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

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. 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.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-14
• Study Start: 2022-11-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01	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	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	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.

Primary Outcome Measures

Name	Time	Method
Dosimetry of normal organs and tumors	through study completion, an average of 4 weeks	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.
Hematologic adverse events collection	through study completion, an average of 6 months	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
Hepatic and renal toxic events collection	through study completion, an average of 6 months	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.

Secondary Outcome Measures

Name	Time	Method
PSA Response	through study completion, an average of 6 months	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%.

Trial Locations

Locations (1)

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