177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT04188587
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2019-01-01
2020-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
177 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.
Interventions
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177 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.
Eligibility Criteria
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Exclusion Criteria
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
18 Years
90 Years
MALE
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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FengWang
Director of Nuclear Medicine
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Ting Bu, M.S
Role: primary
Other Identifiers
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fengwang-177LU-PSMA
Identifier Type: -
Identifier Source: org_study_id