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

• Status: Recruiting
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Criteria

Entry criteria

1. ECOG score: 0-1 point

2. Lymph and skeletal metastases or visceral metastases that cannot be removed surgically

3. 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

1. 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.

2. Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L

3. Glomerular filtration rate<50ml/min

4. Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L.

5. International normalized ratio（INR）>1,5

6. Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value