Metastatic Castration-resistant Prostate Cancer
Conditions
Keywords
177Lu-PSMA-I&T, Prostate cancer
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.
Interventions
DRUG177 Lu-PSMA-I&T
All patients were intravenous injected with single dose 2.0-8.0 GBq. The time of the next treatment cycle is determined according to the patient's condition, and it is recommended to treat once every 8-12 weeks.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA | 2 months | Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease \> 50%, 30% \ 50% and \< 30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events collection | 2 months | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed |
Countries
China
Contacts
Primary ContactFeng Wang, Ph.D
Outcome results
None listed