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PSMA-PET to Guide Prostatectomy

NCT05381103 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-01-31

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Five Eleven Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinton Bahler, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2028-06-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05381103 on ClinicalTrials.gov