SimonMed Imaging
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.
Men aged 18 years or older with a PI-RADS 3 lesion identified on multiparametric MRI within the prior 4 weeks and a clinical indication for prostate biopsy will be consecutively enrolled. After written informed consent, participants will undergo POSLUMA PET/MRI or PET/CT. POSLUMA will be administered as an intravenous bolus at 296 MBq (8 mCi), and imaging will begin approximately 60 minutes after administration. PET-derived metrics, including SUVmax, PRIMARY score, lesion-to-background ratio, and lesion volume, will be recorded. MRI features and clinical parameters, including PSA, PSA density,…
Inclusion Criteria: * Male, age 18 years or older * PI-RADS 3 lesion diagnosed by multiparametric MRI within the past 4 weeks * Clinical indication for prostate biopsy * Undergoing targeted biopsy and systematic biopsy as part of the routine clinical pathway * Able to provide written informed consent Exclusion Criteria: * Prior diagnosis or treatment of prostate cancer * PI-RADS 4 or 5 lesion * Negative MRI, defined as PI-RADS 1 or 2 * Contraindication to PSMA PET or prostate biopsy * Contraindication to both MRI and CT * Any medical condition that may interfere with study procedures
Participants undergo research-only PSMA PET/MRI or PET/CT using POSLUMA (flotufolastat F 18) before clinically indicated prostate biopsy. POSLUMA is administered intravenously at 296 MBq (8 mCi), with PET imaging beginning approximately 60 minutes after administration. PET imaging findings are compared with histopathology from targeted and systematic prostate biopsy.