TheranosticTrials.org

Clinical Trial · NCT04188587

177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer

Overview

The purpose of this study is to determine the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Phase

Phase 2

Contacts

Feng Wang, Ph.D (CONTACT)

fengwangcn@hotmail.com

+8618951670836

ClinicalTrials.gov

NCT04188587

Drug / Compound

PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

  • ECOG score: 0-1 point
  • Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  • International normalized ratio（INR）\>1,5
  • Lymph and skeletal metastases or visceral metastases that cannot be removed surgically
  • Glomerular filtration rate\<50ml/min
  • Hemoglobin\<80g/L;Hemameba\<2.5×109/L;Thrombocyte\<70g/L
  • The disease continues to progress after treatment with ADT, chemotherapy, radiotherapy, or abiraterone and emzaludine 4.68Ga PSMA-11 PET / CT showed that there was significant radioactivity uptake in tumor tissues and metastases \[SUVmax\> 7\], which was significantly higher than that in the liver.Exclusion criteria
  • Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value
  • Entry criteria
  • Serum creatinine\>130umol/L;Total bilirubin\>2mg/L;Albumin\<30g/L.

Exclusion

Exclusion criteria not yet provided.