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ACTIVE NOT RECRUITING
NCT03042468
PHASE1/PHASE2

Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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

DRUG

177Lu-PSMA-617

177Lu-PSMA-617 \[50mCi (1.85GBq) - 300mCi (11.1GBq)\] intravenous X2 doses, 2 weeks apart (Visit 1 and 2)

DRUG

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