2024-07-23 カロリンスカ研究所(KI)
カロリンスカ研究所の研究者によって開発されたストックホルム3(Stockholm3)血液検査は、異なる民族グループにおいても前立腺がんを検出する効果が同等であり、従来のPSA検査よりも優れた結果を示します。Stockholm3は血液サンプルのタンパク質と遺伝マーカーを組み合わせたアルゴリズムを用いて、臨床的に重要な癌の確率を算出します。
◆90,000人以上の男性を対象とした研究では、この検査がPSA標準検査よりも優れた結果を出し、不要なMRIや生検を減らし、低PSA値の男性でも重要な癌を特定することが示されました。アメリカとカナダの多様な民族グループを対象とした研究でも同様の結果が得られ、不要な生検を約半分に減らすことが確認されました。この研究はストックホルム3が白人以外の人々にも有効であることを示し、方法の普及が期待されます。
<関連情報>
- https://news.ki.se/prostate-cancer-blood-test-equally-effective-across-ethnic-groups
- https://ascopubs.org/doi/10.1200/JCO.24.00152
前立腺がん発見のための多民族コホートにおけるストックホルム3(SEPTA): 多施設共同前向き試験 Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial
Hari T. Vigneswaran, MD , Martin Eklund, PhD , Andrea Discacciati, PhD, Tobias Nordström, MD, PhD, Rebecca A. Hubbard, PhD , Nathan Perlis, MD, Michael R. Abern, MD, …
Journal of Clinical Oncology Published:July 22, 2024
DOI:https://doi.org/10.1200/JCO.24.00152
Abstract
Purpose
Asian, Black, and Hispanic men are underrepresented in prostate cancer (PCa) clinical trials. Few novel prostate cancer biomarkers have been validated in diverse cohorts. We aimed to determine if Stockholm3 can improve prostate cancer detection in a diverse cohort.
Methods
An observational prospective multicentered (17 sites) clinical trial (2019-2023), supplemented by prospectively recruited participants (2008-2020) in a urology clinic setting included men with suspicion of PCa and underwent prostate biopsy. Before biopsy, sample was collected for measurement of the Stockholm3 risk score. Parameters include prostate-specific antigen (PSA), free PSA, KLK2, GDF15, PSP94, germline risk (single-nucleotide polymorphisms), age, family history, and previous negative biopsy. The primary endpoint was detection of International Society of Urological Pathology (ISUP) Grade ≥2 cancer (clinically significant PCa, csPC). The two primary aims were to (1) demonstrate noninferior sensitivity (0.8 lower bound 95% CI noninferiority margin) in detecting csPC using Stockholm3 compared with PSA (relative sensitivity) and (2) demonstrate superior specificity by reducing biopsies with benign results or low-grade cancers (relative specificity).
Results
A total of 2,129 biopsied participants were included: Asian (16%, 350), Black or African American (Black; 24%, 505), Hispanic or Latino and White (Hispanic; 14%, 305), and non-Hispanic or non-Latino and White (White; 46%, 969). Overall, Stockholm3 showed noninferior sensitivity compared with PSA ≥4 ng/mL (relative sensitivity: 0.95 [95% CI, 0.92 to 0.99]) and nearly three times higher specificity (relative specificity: 2.91 [95% CI, 2.63 to 3.22]). Results were consistent across racial and ethnic subgroups: noninferior sensitivity (0.91-0.98) and superior specificity (2.51-4.70). Compared with PSA, Stockholm3 could reduce benign and ISUP 1 biopsies by 45% overall and between 42% and 52% across racial and ethnic subgroups.
Conclusion
In a substantially diverse population, Stockholm3 significantly reduces unnecessary prostate biopsies while maintaining a similar sensitivity to PSA in detecting csPC.
