BackgroundMetastatic castration‐refractory prostate cancer (mCRPC) presents a therapeutic challenge despite advancements in treatment. Once mCRPC is attained, patients face limited survival prospects. Next‐line systemic treatment (NEST) is the standard of care for progressive mCRPC, encompassing various therapeutic options with associated toxicity and costs. In patients with oligoprogressive mCRPC, data suggest that progression‐directed therapy (PDT), such as metastasectomy or stereotactic body radiotherapy, delays the initiation of NEST.Methods and DesignThe MEDCARE phase III trial aims to assess the impact of PDT on overall survival (OS) in oligoprogressive mCRPC. In this multicentric, randomised, prospective trial, we aim to randomise 246 patients in 1:1 allocation ratio between the standard‐of‐care therapy (surveillance or NEST) or PDT while continuing the current systemic treatment. Patients will be stratified based on number of progressive lesions (one vs ≥one), location of progressive lesions (local recurrence, N or M1a vs M1b or M1c) and previous systemic therapy (palliative androgen‐deprivation therapy [pADT] vs pADT + androgen receptor‐targeted agent or patients who received docetaxel in the past). The primary endpoint is OS, and the secondary endpoints include quality of life, radiographic progression‐free survival (PFS), modified PFS, prostate cancer‐specific survival and PDT‐induced toxicity.DiscussionThis is the first randomised phase 3 trial in the setting of PDT in patients with oligoprogressive mCRPC with OS as the primary endpoint.

中文翻译：

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进展导向治疗对转移性去势难治性前列腺癌生存率的影响： MEDCARE 3 期试验


背景尽管治疗取得了进展，但转移性去势难治性前列腺癌 （mCRPC） 仍存在治疗挑战。一旦达到 mCRPC，患者的生存前景就会受到限制。下线全身治疗 （NEST） 是进行性 mCRPC 的护理标准，包括各种治疗选择以及相关的毒性和成本。在寡进展型 mCRPC 患者中，数据表明进展导向治疗 （PDT），例如转移切除术或立体定向放疗，会延迟 NEST 的开始。方法和设计MEDCARE III 期试验旨在评估 PDT 对寡进展 mCRPC 总生存期 （OS） 的影响。在这项多中心、随机、前瞻性试验中，我们的目标是在继续目前的全身治疗的同时，以 1：1 的分配比例在标准护理治疗（监测或 NEST）或 PDT 之间随机分配 246 名患者。将根据进行性病变的数量（1 vs ≥1）、进行性病变的位置（局部复发、N 或 M1a 与 M1b 或 M1c）和既往全身治疗（姑息性雄激素剥夺疗法 [pADT] 与 pADT + 雄激素受体靶向药物或过去接受过多西他赛的患者）对患者进行分层。主要终点是 OS，次要终点包括生活质量、影像学无进展生存期 （PFS）、改良 PFS、前列腺癌特异性生存期和 PDT 诱导的毒性。讨论这是第一个以 OS 为主要终点的寡进展 mCRPC 患者在 PDT 背景下的随机 3 期试验。