PSMA PET Scan for Prostate Cancer Surgery

PSMA-PET to Guide Prostatectomy

Recruiting Phase 2 Phase 3 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 80
Sex
Male
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Diagnostic
Participants needed
288 (estimated)
Sponsor
Five Eleven Pharma, Inc. · Industry
Who this trial is looking for

This trial is looking for men with significant prostate cancer who are scheduled for surgery. Participants will undergo either a standard MRI or both an MRI and a PSMA PET scan before their surgery to see if the additional scan helps with treatment plans.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have significant prostate cancer.
  • I have no erectile dysfunction or mild to moderate erectile dysfunction.
  • I want to maintain erections after treatment.
  • I have had a standard MRI or will have one before surgery.
  • I am planning to have prostate surgery within 90 days.

You may not be able to join if

  • I have participated in another research trial involving radiation within the past 30 days.
  • I do not meet the safety criteria for an MRI scan.
  • I have a significant medical or illness issue that could affect my safety or the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% Gleason 3+4 ≥1 core with ≥50% total involvement of core 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 AND 2. Baseline sexual funct…
Contacts

Jennifer Lehman

317-274-1791

jgeck@iu.edu

CONTACT