骨生物标志物对去势抵抗性前列腺癌男性患者整体生存率（OS）的预测能力非常强，但在激素敏感性前列腺癌（HSPC）方面尚未完全建立。骨生物标志物在HSPC中被作为雄激素削减疗法±CYP17抑制剂orteronel的第三期研究的一部分进行了前瞻性评估。患者被随机分为训练组（n=316）和验证组（n=633）。应用递归分区和Cox比例危险模型。从患者血清中评估骨吸收（C末端端肽和吡啶啉）和骨形成标志物（C末端胶原前肽和骨碱性磷酸酶）。在1279名男性中，有949名患者有可评估的基线骨生物标志物。确定了四种生物标志物的升高水平的最佳截止点（所有p <0.05），这些标志物与较差的OS有关联。在验证组中调整了临床风险因素后，升高的骨生物标志物与死亡风险的增加存在显著统计学关联（风险比范围为1.37到1.92）。应用于训练组的递归分区算法识别出三个风险组（低、中、高），根据骨生物标志物的组合确定不同的OS结果（中位OS：8.2、5.1和2.1年），这些结果在验证组中得到了证实。在开始雄激素削减疗法的HSPC男性中，骨生物标志物强烈且独立地预测OS。骨生物标志物的水平单独或与临床协变量相结合，可识别生存期结果不同的男性子集。这些结果验证了骨生物标志物评估在HSPC状态下的临床价值，并将骨生物标志物的实用性扩展到去势抵抗性状态之外。在新诊断的转移性前列腺癌男性中，高水平的骨转换生物标志物与较短的寿命有关。版权所有©2023年欧洲泌尿外科协会。由Elsevier B.V.出版。保留所有权利。

Bone biomarkers are strongly prognostic for overall survival (OS) in men with castration-resistant prostate cancer but not fully established for hormone-sensitive prostate cancer (HSPC).Bone biomarkers in HSPC were prospectively evaluated as part of a phase 3 study of androgen deprivation therapy ± the CYP17 inhibitor orteronel.Patients were randomly divided into training (n = 316) and validation (n = 633) sets. Recursive partitioning and Cox proportional hazard models were employed.Bone resorption (C-telopeptide and pyridinoline) and bone formation markers (C-terminal collagen propeptide and bone alkaline phosphatase) were assessed from patient sera.Of 1279 men, 949 had evaluable baseline bone biomarkers. Optimal cutoffs were identified to define elevated levels of each of the four biomarkers (all p < 0.05) that were associated with worse OS. After adjusting for clinical risk factors in the validation set, elevated bone biomarkers were statistically significantly associated with an increased risk of death (hazard ratios ranging from 1.37 to 1.92). Recursive partitioning algorithms applied to the training set identified three risk groups (low, intermediate, and poor) with differential OS outcomes (median OS: 8.2, 5.1, and 2.1 yr, respectively) based on combinations of bone biomarkers. These results were confirmed in the validation set.In men with HSPC initiating androgen deprivation therapy, bone biomarkers are strongly and independently prognostic for OS. Bone biomarker levels alone or in combination with clinical covariates identify unique subsets of men with differential OS outcomes. These results validate the clinical value of bone biomarker assessment in the HSPC state, extending bone biomarker utility beyond the castration-resistant state.In men with newly diagnosed metastatic prostate cancer, high levels of bone turnover biomarkers are associated with a shorter lifespan.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.