177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
Safety and Dosimetry of 177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
2 other identifiers
interventional
30
1 country
1
Brief Summary
This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-EB-PSMA-617. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617 within one week, then monitored at 2, 24, 72, 120 and 168 h after 177Lu-EB-PSMA617 administration with serial whole body planar and SPECT/CT imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2017
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
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 11, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 18, 2018
November 1, 2017
1 year
January 11, 2018
January 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Standardized uptake value of 177Lu-EB-PSMA617 in normal organs and metastatic castration-resistant prostate cancer.
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and metastatic castration-resistant prostate cancer will be measured
1 year
Secondary Outcomes (1)
Adverse events collection
2 months
Study Arms (1)
177Lu-EB-PSMA-617 dosimetry calculation
EXPERIMENTALAll patients were intravenous injected with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617, then monitored at 2, 24, 72, 120 and 168 hours post-injection.
Interventions
accepted intravenous injection of 177Lu-EB-PSMA-617 and monitored at 2, 24, 72, 120 and 168 hours post-injection.
Eligibility Criteria
You may qualify if:
- All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy. Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Zhaohui Zhu, MD,PHD
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2018
First Posted
January 18, 2018
Study Start
December 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 18, 2018
Record last verified: 2017-11