๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-01-29

PSMA-PET to Guide Prostatectomy (NCT05381103)

PSMA-PET to Guide Prostatectomy: A Randomized Trial

๐ŸŸข Recruiting Phase2 / Phase3 ๐Ÿ“‹ Clinical Research Protocol Sponsor: Five Eleven Pharma, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine โ€” Indianapolis, Indiana

Age range: 40 Years to 80 Years

๐Ÿงช Interventions in This Study

  • PSMA-PET and SOC MRI (DIAGNOSTIC_TEST)
  • SOC MRI (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine โ€” Indianapolis, Indiana

๐Ÿ“ž Contact the Study Coordinator

Phone: (317) 274-1791

Email: jgeck@iu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Prostate Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—