Urology Service, Department of Surgery, Windsor Regional Hospital, University of Western Ontario, Windsor, Ontario, Canada.
Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
Urol Oncol. 2019 Oct;37(10):672-677. doi: 10.1016/j.urolonc.2019.07.010. Epub 2019 Aug 2.
Recent years have seen the development of biomarkers and imaging technologies designed to improve the specificity of PSA. Widespread implementation of imaging technologies, such as mp-MRI raises considerable logistical challenges. Our objective was to evaluate a biopsy strategy that utilizes selective mp-MRI as a follow-up test to biomarkers to improve the detection of significant prostate cancer.
We developed a conceptual approach based on the risk calculated from the 4Kscore using results from the US prospective validation study, multiplied by the likelihood ratio of mp-MRI from the PROMIS trial. The primary outcome was Gleason grade ≥ 7 (grade group ≥ 2) cancer on biopsy. Using decision curve analysis, the net benefit was determined for our model and compared with the use of the 4Kscore and mp-MRI independently at various thresholds for biopsy.
For a cut-point of 7.5% risk of high-grade disease, patients with <5% risk from a blood marker would not have risk of significant prostate cancer sufficiently increased by a positive mp-MRI to warrant biopsy; comparably, patients with a risk >23% would not have risk sufficiently reduced by a negative imaging study to forgo biopsy. From the 4Kscore validation study, 46% of men considered for biopsy in the US have risks 5% to 23%. Net benefit was highest for the combined strategy, followed by 4Kscore alone.
Selective mp-MRI in men with intermediate scores on a secondary blood test results in a biopsy strategy that is more scalable than mp-MRI for all men with elevated PSA. Prospective validation is required to demonstrate if the predicted properties of combined blood and imaging testing are empirically confirmed.
近年来，人们开发了旨在提高 PSA 特异性的生物标志物和成像技术。广泛应用成像技术，如 mp-MRI，带来了相当大的后勤挑战。我们的目标是评估一种活检策略，该策略利用选择性 mp-MRI 作为生物标志物的后续测试，以提高对显著前列腺癌的检测。
我们基于使用来自美国前瞻性验证研究的结果计算的 4Kscore 风险，结合 PROMIS 试验中 mp-MRI 的似然比，开发了一种基于概念的方法。主要结局是活检时存在 Gleason 分级≥7（分级组≥2）的癌症。使用决策曲线分析，确定了我们模型的净收益，并将其与独立使用 4Kscore 和 mp-MRI 在不同活检阈值下的效果进行了比较。
对于高级别疾病风险为 7.5%的截断点，如果血液标志物的风险<5%，则阳性 mp-MRI 不会显著增加患者患前列腺癌的风险，需要进行活检；类似地，如果风险>23%，则阴性影像学研究不会显著降低患者的风险，不需要进行活检。从 4Kscore 验证研究来看，在美国考虑进行活检的男性中，有 46%的男性的风险在 5%到 23%之间。联合策略的净收益最高，其次是 4Kscore 单独使用。
在二次血液检测结果处于中间水平的男性中选择性使用 mp-MRI 可使活检策略更具可扩展性，而不是所有 PSA 升高的男性都使用 mp-MRI。需要前瞻性验证来证明联合血液和成像检测的预测性能是否得到经验证实。
