Clinical trial NCT04188587: 177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
Official title: 177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: 177Lu-PSMA-I&T
Prostate cancer
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: PSA
timeFrame: 2 months
Secondary outcomes:
measure: Adverse events collection
timeFrame: 2 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: