TheranosticTrials.org

Clinical Trial · NCT07916311

POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions

Overview

This prospective, multicenter diagnostic accuracy study will evaluate whether POSLUMA (flotufolastat F 18) PET/MRI or PET/CT can detect clinically significant prostate cancer, defined as Gleason score 7 or higher, in adult men with PI-RADS 3 lesions on recent multiparametric MRI and a clinical indication for prostate biopsy. Participants will undergo a research-only POSLUMA PET scan before targeted and systematic prostate biopsy. PET imaging metrics and clinical variables will be compared with histopathology. Research PET results will not be used to guide clinical management or replace standard diagnostic procedures.

Sponsor

SimonMed Imaging

Phase

N/A

Contacts

Howard John Simon, MD (PRINCIPAL_INVESTIGATOR)

Xiaowei Hong (CONTACT)

adeline.hong@simonmed.com

702-433-6944

ClinicalTrials.gov

NCT07916311

Drug / Compound

flotufolastat

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Undergoing targeted biopsy and systematic biopsy as part of the routine clinical pathway
  • PI-RADS 3 lesion diagnosed by multiparametric MRI within the past 4 weeks
  • Clinical indication for prostate biopsy

Exclusion

  • Any medical condition that may interfere with study procedures
  • PI-RADS 4 or 5 lesion
  • Contraindication to both MRI and CT
  • Prior diagnosis or treatment of prostate cancer
  • Negative MRI, defined as PI-RADS 1 or 2
  • Contraindication to PSMA PET or prostate biopsy