The impact of progression-directed therapy on survival in metastatic castration-refractory prostate cancer: MEDCARE phase 3 trial.

IF 3.7 2区医学 Q1 UROLOGY & NEPHROLOGY

BJU International Pub Date : 2024-11-06 DOI:10.1111/bju.16574

Kato Rans, Karolien Goffin, Steven Joniau, Gedske Daugaard, Julie den Hartog, Lodewijk Van Wynsberge, Gert De Meerleer

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引用次数: 0

Abstract

Background: Metastatic 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 design: The 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.

Discussion: This is the first randomised phase 3 trial in the setting of PDT in patients with oligoprogressive mCRPC with OS as the primary endpoint.

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进展导向疗法对转移性难治性前列腺癌患者生存期的影响：MEDCARE 3期试验。

背景：尽管治疗手段不断进步，但转移性难治性前列腺癌（mCRPC）仍是一项治疗难题。一旦患上mCRPC，患者的生存前景十分有限。下线系统治疗（NEST）是进展期mCRPC的标准治疗方法，包括各种治疗方案，但都有相关的毒性和费用。对于少进展期mCRPC患者，有数据表明，转移灶切除术或立体定向体放疗等进展导向疗法（PDT）可延迟NEST的启动：MEDCAREⅢ期试验旨在评估PDT对少进展mCRPC患者总生存期（OS）的影响。在这项多中心、随机、前瞻性试验中，我们旨在以 1:1 的分配比例随机分配 246 名患者，让他们接受标准治疗（监测或 NEST）或 PDT，同时继续接受当前的系统治疗。患者将根据进展病灶的数量（一个 vs ≥一个）、进展病灶的位置（局部复发、N或M1a vs M1b或M1c）和既往接受过的系统治疗（姑息性雄激素剥夺疗法 [pADT] vs pADT + 雄激素受体靶向药物或既往接受过多西他赛治疗的患者）进行分层。主要终点为OS，次要终点包括生活质量、放射学无进展生存期（PFS）、改良PFS、前列腺癌特异性生存期和PDT诱导的毒性：这是首个以OS为主要终点的PDT治疗少进展mCRPC患者的随机3期试验。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BJU International 医学-泌尿学与肾脏学

CiteScore

9.10

自引率

4.40%

发文量

262

审稿时长

1 months

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