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

Nanjing Medical University

Status and phase: Unknown; Phase 2

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Drug: 177 Lu-PSMA-I&T

Study type: Interventional

Funder types: Other

Identifiers

NCT04188587

fengwang-177LU-PSMA

Details and patient eligibility

About

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.

Full description

Prostate specific membrane antigen(PSMA) targeted therapy brings new hope to the patients with metastatic castration-resistant prostate cancer (mCRPC). Here, we reported the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.

Prostate cancer is the most common cancer diagnosed in older men with recent data .PSMA is a type II transmembrane glycoprotein，overexpressed up to 100 to 1000 times higher than normal prostate cells in prostate cancer cells and is correlated with higher-grade cancers, metastatic disease and hormone refractory disease. Lutetium-177 (177Lu)-PSMA (LuPSMA) is a novel and highly targeted systemic RLT for progressive mCRPC. Upon binding of LuPSMA to the cell membrane, endocytosis is triggered, concentrating the tumouricidal effects of the radioisotope activity internally within malignant cells.

This is a single-institution, single-arm phase 2 clinical trial. Patients will receive PRLT Treatment. The follow-up period was followed up to assess safety and effectiveness.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

177Lu-PSMA-I&T

Experimental group

Description:

177Lu-PSMA-I＆Tradioligand therapy with 2.0-8.0GBq in every circle were performed. And then 177Lu-PSMA post-therapy scans were performed at 24 h and 48 h respectively, and the fusion phenomenon was performed at the second day to pre evaluate the efficacy of the patients.

Treatment:

Drug: 177 Lu-PSMA-I&T