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

NCT05613738 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-07-10

No results posted yet for this 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.

Conditions

Interventions

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Zhaohui Zhu Zhu, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2025-06-30
Completion
2025-11-15

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613738 on ClinicalTrials.gov