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

Last updated: July 8, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Prostate Cancer, Early, Recurrent

Prostate Cancer

Treatment

2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01

1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01

Clinical Study ID

NCT05613738
PUMCH-NM-PSMAEB01
  • Ages 18-80
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • progressive metastatic castration-resistant prostate cancer

  • tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT

Exclusion

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

Total Participants: 9
Treatment Group(s): 3
Primary Treatment: 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01
Phase:
Study Start date:
November 23, 2022
Estimated Completion Date:
November 15, 2025

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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