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Recruiting Phase 2Phase 3 Interventional

PSMA-PET to Guide Prostatectomy

ClinicalTrials.gov ID: NCT05381103

Public ClinicalTrials.gov record NCT05381103. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PSMA-PET to Guide Prostatectomy: A Randomized Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05381103
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Five Eleven Pharma, Inc.
Industry
Enrollment
288 participants

Conditions and interventions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2021
Primary completion
May 31, 2028
Completion
Nov 30, 2028
Last update posted
Jan 30, 2025

2021 – 2028

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine Indianapolis Indiana 46202 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05381103, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 30, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05381103 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →