Background

It has been shown that the Stockholm-3 model (S3M) outperforms prostate-specific antigen (PSA) as a screening tool for prostate cancer.

Objective

To update the S3M, to give a detailed account of the value of each predictor in the S3M, and to evaluate the S3M as a reflex test for men with PSA ≥3 ng/ml.

Design, setting, and participants

During 2012–2015, the Stockholm-3 study evaluated the S3M relative to PSA as tests for Gleason score ≥7 prostate cancers among men aged 50–69 yr. The participants (n = 59 159) underwent both tests, and biopsy was recommended if at least one was positive. A total of 5073 men had a biopsy because of elevated PSA (≥3 ng/ml).

Outcome measurements and statistical analysis

Logistic regression was used to update the S3M: intact PSA was removed, HOXB13 was included, and the model was fitted to data from the Stockholm-3 training and validation cohorts. To compare S3M with PSA, we fixed the sensitivity for detection of high-grade cancer and evaluated the performance as the number of biopsies needed to achieve that sensitivity for each test.

Results and limitations

The updated S3M slightly improved the area under the receiver operating characteristic curve compared to previously published results (0.75 vs 0.74). When used as a reflex test for men with PSA ≥3 ng/ml, S3M reduced the number of biopsies needed by 34% compared to the use of PSA alone, with equal sensitivity. A limitation is the ethnically homogeneous population.

Conclusions

A major problem with PSA screening—too many unnecessary biopsies—can be mitigated if S3M is used as a reflex test.

Patient summary

To find aggressive prostate cancer with the minimum number of negative biopsies and detection of clinically insignificant cancers, we evaluated the use of a personalized diagnostic prediction model as a second test for men with a positive prostate-specific antigen (PSA) test. We found that this two-step approach could reduce prostate biopsies by a third compared to using PSA alone.

中文翻译：

---

用于前列腺癌检测的 Stockholm-3 模型：算法更新、生物标志物贡献和反射测试潜力

背景

已经表明，斯德哥尔摩-3 模型 (S3M) 作为前列腺癌的筛查工具优于前列腺特异性抗原 (PSA)。

客观的

更新 S3M，详细说明 S3M 中每个预测因子的值，并评估 S3M 作为 PSA ≥3 ng/ml 男性的反射测试。

设计、设置和参与者

在 2012-2015 年期间，Stockholm-3 研究评估了 S3M 相对于 PSA 作为对 50-69 岁男性 Gleason 评分≥7 前列腺癌的测试。参与者 ( n  = 59 159) 接受了两项测试，如果至少一项为阳性，则建议进行活检。由于 PSA 升高（≥3 ng/ml），共有 5073 名男性进行了活检。

结果测量和统计分析

逻辑回归用于更新 S3M：移除完整的 PSA，包括HOXB13，并将模型拟合到来自 Stockholm-3 训练和验证队列的数据。为了将 S3M 与 PSA 进行比较，我们固定了检测高级别癌症的灵敏度，并将性能评估为每次测试达到该灵敏度所需的活检数量。

结果和限制

与之前公布的结果相比，更新后的 S3M 略微改善了接收者操作特征曲线下的面积（0.75 对 0.74）。当用作 PSA ≥ 3 ng/ml 男性的反射测试时，与单独使用 PSA 相比，S3M 将所需的活检数量减少了 34%，具有相同的灵敏度。一个限制是种族同质的人口。

结论

如果将 S3M 用作反射测试，则可以缓解 PSA 筛查的一个主要问题——过多的不必要的活检。

患者总结

为了以最少数量的阴性活检和检测出临床上无意义的癌症来发现侵袭性前列腺癌，我们评估了使用个性化诊断预测模型作为对前列腺特异性抗原 (PSA) 测试呈阳性的男性的第二次测试。我们发现，与单独使用 PSA 相比，这种两步法可以将前列腺活检减少三分之一。