Actively Recruiting

Phase 2
Phase 3
Age: 40Years - 80Years
MALE
NCT05381103

PSMA-PET to Guide Prostatectomy

Led by Five Eleven Pharma, Inc. · Updated on 2025-01-31

288

Participants Needed

1

Research Sites

374 weeks

Total Duration

On this page

Sponsors

F

Five Eleven Pharma, Inc.

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

PSMA-PET to Guide Prostatectomy

Who Can Participate

Age: 40Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 40 to 80 years
  • Significant prostate cancer defined by Gleason 3+4 with ≥1 core pattern 4 ≥20%, or Gleason 3+4 with ≥50% total core involvement or ≥3 cores of Gleason 3+4, or NCCN unfavorable intermediate risk, or any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5
  • Baseline sexual function with IIEF-EF score greater than 17 (no or mild-to-moderate erectile dysfunction)
  • Desire to maintain erections after treatment
  • Planned to undergo or recently completed a standard of care MRI within 6 months before surgery (MRI may be repeated as research at no cost if needed)
  • Planned prostatectomy within 90 days of consent as determined by treating oncologist
Not Eligible

You will not qualify if you...

  • Participation in another investigational trial involving ionizing radiation within 30 days or concurrently
  • Not meeting safety criteria for MRI (e.g., disallowed metal implants)
  • Significant acute or chronic medical, neurologic, or other illness that may threaten safety, limit study completion, or affect study objectives as judged by the Principal Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

J

Jennifer Lehman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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