Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values \[SUV\]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
55
Positron emission tomography (PET)
Positron emission tomography (PET)
Mayo Clinic
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Tower Urology
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
To compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F).
Time frame: Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
To assess the following for piflufolastat (18F) PET and flotufolastat (18F) PET: Detection rates; Detection rates stratified by PSA level; Prostate bed detection rates: local recurrences by subregion; Pelvic lymph node (PLN) detection rates
Estimate of the following for each radiopharmaceutical: Patient-level detection rate; Patient-level detection rate by baseline PSA categories; Detection rate for local recurrences in prostate bed for the following subregions: vesicourethral anastomosis lesions; retrovesical lesions; remnant seminal vesicles/lateral surgical margin lesions; Detection rate for PLN lesions.
Time frame: Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
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