Clinical Trials /

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

NCT03403595

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
  • Official Title: Safety and Dosimetry of 177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: PekingUMCH-NM16
  • SECONDARY ID: ZIAEB000073
  • NCT ID: NCT03403595

Conditions

  • Metastatic Castration-resistant Prostate Cancer

Interventions

DrugSynonymsArms
177Lu-EB-PSMA-617177Lu-EB-PSMA-617 dosimetry calculation

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
177Lu-EB-PSMA-617 dosimetry calculationExperimentalAll 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.
  • 177Lu-EB-PSMA-617

Eligibility Criteria

        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.
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:Standardized uptake value of 177Lu-EB-PSMA617 in normal organs and metastatic castration-resistant prostate cancer.
Time Frame:1 year
Safety Issue:
Description: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

Measure:Adverse events collection
Time Frame:2 months
Safety Issue:
Description:Adverse events within 2 months after the injection and scanning of patients will be followed and assessed

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Peking Union Medical College Hospital

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