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Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer

NCT03780075 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-12

No results posted yet for this study

Summary

In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to increase the tumor accumulation and retention for radioligand therapy，and then the investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients with mCRPC.

This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi), 2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously. All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.

Conditions

Interventions

DRUG

1.11GBq of 177Lu-EB-PSMA-617

Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

DRUG

2.00 GBq of 177Lu-EB-PSMA-617

Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

DRUG

3.70GBq of 177Lu-EB-PSMA-617

Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Zhaohui Zhu, MD,PHD · Peking Union Medical College Hospital, Chinese Academy of Medical Science

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
2018-04-15
Primary Completion
2020-09-01
Completion
2022-12-01

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 NCT03780075 on ClinicalTrials.gov