Flotufolastat F 18 (US commerce title, Posluma) demonstrated promising diagnostic efficiency in African American males with recurrent prostate most cancers, in accordance with a submit hoc evaluation of the part 3 SPOTLIGHT trial (NCT04186845).1
In whole, the SPOTLIGHT trial enrolled 366 sufferers with recurrent prostate most cancers, 61 of which have been African American.
Flotufolastat F 18 acquired FDA approval in Could 2023 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in sufferers with prostate most cancers with suspected metastasis who’re candidates for preliminary definitive remedy or who’ve suspected recurrence primarily based on an elevated serum prostate-specific antigen (PSA) degree.
“Past validating the diagnostic efficiency of POSLUMA in African American males, findings from the SPOTLIGHT research present helpful concerns for planning future medical trials, to facilitate affected person enrollment and obtain medical trial variety,” mentioned Marco Campione, CEO of Blue Earth Diagnostics, in a information launch on the findings.2 “The outcomes achieved in African American males have been derived from medical websites throughout the USA, and additional assist the broad applicability of POSLUMA for its indicated use throughout the US inhabitants as an entire.”
General, 17% (61/366) of males included within the SPOTLIGHT trial have been African American. In keeping with the authors, that is considerably larger than the proportion of African American sufferers usually seen in different forms of oncology medical trials, with a reported fee of 8.5%. The 17% fee noticed within the SPOTLIGHT trial can be consultant of the US inhabitants, during which roughly 14% of individuals are African American.
Information from the post-hoc evaluation confirmed a excessive patient-level detection fee for flotufolastat F 18 in African American sufferers, with 93% having a constructive scan. The detection fee elevated from 67% in African American sufferers with a PSA lower than 0.5 ng/mL to 100% amongst these with a PSA of 10 ng/mL or larger. Amongst all different individuals within the research, the detection fee with flotufolastat F 18 was 87%.
Amongst sufferers who underwent a prostatectomy, the detection charges have been related between all ethnic teams. In sufferers with intact prostates, the next detection fee was noticed for African American males vs all different sufferers.
Additional, the verified detection fee (VDR) amongst African American sufferers was 64%, vs 55% amongst all different sufferers. The constructive predictive worth (PPV) was 68% amongst African American sufferers and 64% amongst all different sufferers.
“Prostate most cancers is essentially the most generally recognized most cancers amongst African American males, who’re twice extra more likely to die from the illness than White males. It’s encouraging that African American enrollment within the SPOTLIGHT trial intently aligns with their 14% illustration of the US inhabitants, as a result of outcomes from oncology trials with low variety populations are much less helpful for medical decision-making and may contribute to racial disparities in most cancers outcomes,” mentioned lead creator Soroush Rais-Bahrami, MD, MBA, within the information launch.2 Rais-Bahrami is a professor of urology and radiology and the interim chair of urology on the College of Alabama at Birmingham Heersink College of Medication in Birmingham, Alabama.
In whole, the SPOTLIGHT trial enrolled 366 sufferers with recurrent prostate most cancers, 61 of which have been African American and have been included within the present post-hoc evaluation. All sufferers within the SPOTLIGHT trial underwent PET/CT 50 to 70 minutes following intravenous administration of 296 MBq of flotufolastat F 18.
For the research, commonplace of fact verification for VDR and PPV was established with histopathology or correlative imaging. In keeping with the authors, standard-of-truth verified VDR is equal to detection fee x PPV.
General, the authors concluded, “The information evaluated on this research assist to reveal the broad applicability of newly authorised 18F-flotufolastat to the US inhabitants as an entire.”1
References
1. Rais-Bahrami S, Fleming M, Gartrell B, et al. 18F-Flotufolastat positron emission tomography in African American sufferers with suspected prostate most cancers recurrence: Findings from the part 3 SPOTLIGHT research. Advances in Radiation Oncology. doi:10.1016/j.adro.2024.101571
2. Blue Earth Diagnostics, a Bracco Firm, declares outcomes evaluating diagnostic efficiency of POSLUMA (Flotufolastat F 18) and medical trial enrollment in African American males with prostate most cancers. Information launch. Blue Earth Diagnostics. Revealed on-line and accessed July 30, 2024. https://www.businesswire.com/information/dwelling/20240730333904/en/Blue-Earth-Diagnostics-a-Bracco-Firm-Declares-Outcomes-Evaluating-Diagnostic-Efficiency-of-POSLUMApercentC2percentAE-Flotufolastat-F-18-and-Medical-Trial-Enrollment-in-African-American-Males-with-Prostate-Most cancers
