Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
MALE
NCT05613738

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

Led by Peking Union Medical College Hospital · Updated on 2024-07-10

9

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Progressive metastatic castration-resistant prostate cancer
  • Tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT
Not Eligible

You will not qualify if you...

  • Serum creatinine level greater than 150 µmol per liter
  • Hemoglobin level less than 10.0 g/dl
  • White-cell count less than 4.0×10⁹/L
  • Platelet count less than 100×10⁹/L
  • Total bilirubin level more than 3 times the upper limit of normal
  • Serum albumin level more than 3.0 g per deciliter
  • Cardiac insufficiency

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

Z

Zhaohui Zhu, MD

CONTACT

G

Guochang Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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