Biochemical recurrence (BCR) after primary treatments for prostate cancer (PC) is an extremely heterogeneous phase and at least a stratification into low- and high-risk cases for early progression in metastatic disease is necessary. At present, PSA-DT represents the best parameter to define low- and high-risk BCR PC, but real precision medicine is strongly suggested to define tailored management for patients with BCR. Before defining management, it is necessary to exclude the presence of low-volume metastasis associated with PSA progression using new-generation imaging, preferably with PSMA PET/CT. Low-risk BCR cases should be actively observed without early systemic therapies. Early treatment of low-risk BCR with continuous androgen deprivation therapy (ADT) can produce disadvantages such as the development of castration resistance before the appearance of metastases (non-metastatic castration-resistant PC). Patients with high-risk BCR benefit from early systemic therapy. Even with overall survival (OS) as the primary treatment endpoint, metastasis-free survival (MFS) should be used as a surrogate endpoint in clinical trials, especially in long survival stages of the disease. The EMBARK study has greatly influenced the management of high-risk BCR, by introducing the concept of anticipation and intensification through the use of androgen receptor signaling inhibitors (ARSIs) and ADT combination therapy. In high-risk (PSA-DT ≤ 9 months) BCR cases, the combination of enzalutamide with leuprolide significantly improves MFS when compared to leuprolide alone, maintaining an unchanged quality of life in the asymptomatic phase of the disease. The possibility of using ARSIs alone in this early disease setting is suggested by the EMBARK study (arm with enzalutamide alone) with less evidence than with the intensification of the combination therapy. Continued use versus discontinuation of enzalutamide plus leuprolide intensified therapy upon reaching undetectable PSA levels needs to be better defined with further analysis. Real-world analysis must verify the significant results obtained in the context of a phase 3 study.
前列腺癌（PC）初次治疗后出现的生化复发（BCR）是一个高度异质性的阶段，至少需要根据早期进展为转移性疾病的风险将其分为低危和高危病例。目前，PSA倍增时间（PSA-DT）是区分低危与高危BCR前列腺癌的最佳参数，但强烈建议采用真正的精准医学方法为BCR患者制定个体化管理方案。在确定治疗方案前，必须使用新一代影像学技术（优选PSMA PET/CT）排除与PSA进展相关的低负荷转移灶。低危BCR病例应采取主动监测，避免早期全身治疗。对低危BCR患者过早采用持续雄激素剥夺疗法（ADT）可能产生不利影响，例如在转移灶出现前发展为去势抵抗性前列腺癌（非转移性去势抵抗性PC）。高危BCR患者则能从早期全身治疗中获益。即使以总生存期（OS）为主要治疗终点，在临床试验中（尤其是疾病长期生存阶段）也应将无转移生存期（MFS）作为替代终点。EMBARK研究通过引入雄激素受体信号抑制剂（ARSIs）联合ADT的强化治疗方案，前瞻性地改变了高危BCR的治疗策略。对于高危（PSA-DT ≤ 9个月）BCR病例，与单用亮丙瑞林相比，恩扎卢胺联合亮丙瑞林能显著改善MFS，同时在疾病无症状期维持生活质量不变。EMBARK研究（恩扎卢胺单药组）提示在此早期疾病阶段单独使用ARSIs的可能性，但其证据强度弱于联合强化治疗方案。当达到不可检测PSA水平后，继续使用或停用恩扎卢胺联合亮丙瑞林的强化治疗方案，仍需通过进一步分析明确。真实世界分析必须验证3期临床试验中取得的显著成果。
肿瘤(癌症)患者之家