177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedDecember 6, 2019
December 1, 2019
1.6 years
December 4, 2019
December 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PSA
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 Outcomes (1)
Adverse events collection
2 months
Study Arms (1)
177Lu-PSMA-I&T
EXPERIMENTAL177Lu-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.
Interventions
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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Nuclear Medicine
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 6, 2019
Study Start
January 1, 2019
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
December 6, 2019
Record last verified: 2019-12