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RECRUITING
NCT05381103
PHASE2/PHASE3

PSMA-PET to Guide Prostatectomy

Sponsor: Five Eleven Pharma, Inc.

View on ClinicalTrials.gov

Summary

In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.

Official title: PSMA-PET to Guide Prostatectomy: A Randomized Trial

Key Details

Gender

MALE

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2021-10-01

Completion Date

2028-12-01

Last Updated

2025-01-31

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

PSMA-PET and SOC MRI

60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT

DIAGNOSTIC_TEST

SOC MRI

Standard of care MRI

Locations (1)

Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine

Indianapolis, Indiana, United States