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Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC
Sponsor: Weill Medical College of Cornell University
Summary
The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617 that can be given without severe side effects for advanced prostate cancer.
Official title: Phase I/ll Dose-escalation Study of Fractionated Dose 177Lu-PSMA-617 for Progressive Metastatic Castration Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2016-12
Completion Date
2026-08
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
177Lu-PSMA-617
177Lu-PSMA-617 \[50mCi (1.85GBq) - 300mCi (11.1GBq)\] intravenous X2 doses, 2 weeks apart (Visit 1 and 2)
68Ga-PSMA-HBED-CC
68Ga-PSMA-HBED-CC \[5 ±2mCi or 185 ±74MBq\] intravenous during screening and at 12 weeks with standard imaging
Locations (2)
Tulane Cancer Center Clinic
New Orleans, Louisiana, United States
Weill Cornell Medical College
New York, New York, United States