Blue Earth Diagnostics Announces Positive Results from Head-to-Head Comparator Study of POSLUMA® (Flotufolastat F 18) and Piflufolastat F 18 Urinary Bladder Radioactivity in Men with Biochemical Recurrence of Prostate Cancer
Excerpt from the Press Release:
BOSTON, Feb. 27, 2026 /PRNewswire/ — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced results from the first head-to-head study comparing urinary bladder radioactivity between two prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals. This prospective, multicenter, intra-patient comparison evaluated urinary radioactivity and lesion detection rates of POSLUMA® (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy.
The study met its primary endpoint, demonstrating statistically significant lower urinary bladder radioactivity with POSLUMA compared with piflufolastat F 18, as measured by mean standardized uptake value (SUVmean). Across 55 evaluable patients, median bladder SUVmean was 10.9 for POSLUMA and 29.0 for piflufolastat F 18, with a median difference of 15.1 (interquartile range, 8.5–27.0; p<0.001). Lower urinary radioactivity may help optimize image assessment in regions close to the bladder and ureters, where small recurrent prostate cancer lesions can be challenging to distinguish from urinary activity.
Secondary analyses showed higher patient-level and region-level detection rates with POSLUMA compared with piflufolastat F 18, including among patients with very low PSA levels (≤0.2 ng/mL). In this subgroup, majority-read patient-level detection rates were 52.4% with POSLUMA and 38.1% with piflufolastat F 18. Detection rates were also higher with POSLUMA in the prostate bed and extra-pelvic regions.
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