177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210006
- Recruiting
- Nanjing First Hospital
-
Contact:
- Ting Bu, M.S
- Phone Number: +8602552271456
- Email: 1062238525@qq.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Entry criteria
- ECOG score: 0-1 point
- Lymph and skeletal metastases or visceral metastases that cannot be removed surgically
- 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
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.
- Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L
- Glomerular filtration rate<50ml/min
- Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L.
- International normalized ratio（INR）>1,5
- Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 177Lu-PSMA-I&T
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSA
Time Frame: 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%.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events collection
Time Frame: 2 months
|
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed
|
2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- fengwang-177LU-PSMA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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