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Prostate CancerDiagnostics and screeningProstate healthMen's healthDiagnostic testPhase 2, Phase 3

What this study is

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.

What's being tested

  • PSMA-PET and SOC MRI

    Intervention · DIAGNOSTIC TEST

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

  • SOC MRI

    Intervention · DIAGNOSTIC TEST

    Standard of care MRI

Study details

Official title
PSMA-PET to Guide Prostatectomy: A Randomized Trial
Sponsor
Five Eleven Pharma, Inc.
Conditions
Prostate Cancer
Enrolling
288 people
Starts
2021-10-01
Est. completion
2028-12-01
Design
Single-blind, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗