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

RECRUITINGN/ASponsored by Peking Union Medical College Hospital
Actively Recruiting
PhaseN/A
SponsorPeking Union Medical College Hospital
Started2022-11-23
Est. completion2025-06-30
Eligibility
Age18 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05613738

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

Age: 18 Years – 80 YearsSex: MALEHealthy volunteers accepted
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

Conditions2

CancerMetastatic Castration-resistant Prostate Cancer

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