A randomised trial of short- vs long-term androgen deprivation with salvage radiotherapy for biochemical failure following radical prostatectomy: URONCOR 06-24

IF 3.7 2区医学 Q1 UROLOGY & NEPHROLOGY BJU International Pub Date : 2024-07-23 DOI:10.1111/bju.16484

Carmen González-San Segundo, Fernando López Campos, Alfonso Gómez Iturriaga, Aurora Rodríguez, Jesús Olivera, Víctor Duque-Santana, Gemma Sancho, Iván Henríquez, Antonio José Conde, Jeannette Valero, Xavier Maldonado, Luis Glaria, Begoña Caballero, Noelia Sanmamed, Joel Mases, Anna María Boladeras-Inglada, Miguel Montijano, Marina Santos, Ana Álvarez, Juan I. Martínez, Felipe Couñago

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Abstract

Background

Salvage radiotherapy (SRT) and androgen-deprivation therapy (ADT) are widely used in routine clinical practice to treat patients with prostate cancer who develop biochemical recurrence (BCR) after radical prostatectomy (RP). However, there is no standard-of-care consensus on optimal duration ADT. Investigators propose three distinct risk groups in patients with prostate cancer treated with SRT in order to better define the indications and duration of ADT combined with SRT.

Study design

The URONCOR 06-24 trial (ClinicalTrials.gov identifier NCT05781217) is a prospective, multicentre, randomised, open-label, phase III, clinical trial. The aim of the trial is to determine the impact of short-term (6 months) vs long-term (24 months) ADT in combination with SRT on distant metastasis-free survival (MFS) in patients with prostate cancer with BCR after RP (intermediate and high risk).

Endpoints

The primary endpoint is 5-year MFS rates in patients with prostate cancer treated with long- vs short-term ADT in combination with SRT. Secondary objectives are biochemical-relapse free interval, pelvic progression-free survival, time to start of systemic treatment, time to castration resistance, cancer-specific survival, overall survival, acute and late toxicity, and quality of life.

Methods and analysis

Total of 534 patients will be randomised 1:1 to ADT 6 months or ADT 24 months with a luteinizing hormone-releasing hormone analogue in combination with SRT, stratified by risk group and pathological lymph node status.

Ethics and dissemination

The study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.

Trial registration number

EudraCT number 2021-006975-41.

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针对根治性前列腺切除术后生化治疗失败的短期与长期雄激素剥夺及挽救性放疗随机试验：URONCOR 06-24。

背景：挽救性放疗（SRT）和雄激素剥夺疗法（ADT）在常规临床实践中被广泛用于治疗根治性前列腺切除术（RP）后出现生化复发（BCR）的前列腺癌患者。然而，目前尚未就 ADT 的最佳持续时间达成共识。研究人员建议对接受 SRT 治疗的前列腺癌患者分为三个不同的风险组，以便更好地确定 ADT 联合 SRT 的适应症和持续时间：URONCOR 06-24试验（ClinicalTrials.gov标识符NCT05781217）是一项前瞻性、多中心、随机、开放标签的III期临床试验。该试验旨在确定短期（6 个月）与长期（24 个月）ADT 联合 SRT 对 RP 后 BCR 的前列腺癌患者（中高危）无远处转移生存期（MFS）的影响：主要终点是接受长期与短期 ADT 联合 SRT 治疗的前列腺癌患者的 5 年无远处转移生存率。次要目标是无生化复发间隔期、盆腔无进展生存期、开始系统治疗的时间、出现阉割抵抗的时间、癌症特异性生存期、总生存期、急性和晚期毒性以及生活质量：共有534名患者将按1:1的比例随机接受ADT 6个月或ADT 24个月与促黄体生成素释放激素类似物联合SRT治疗，并根据风险组别和病理淋巴结状态进行分层：本研究在世界医学协会《赫尔辛基宣言》的指导原则下进行。研究结果将在研究会议和同行评审期刊上公布：EudraCT 编号：2021-006975-41。

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

期刊介绍： BJUI is one of the most highly respected medical journals in the world, with a truly international range of published papers and appeal. Every issue gives invaluable practical information in the form of original articles, reviews, comments, surgical education articles, and translational science articles in the field of urology. BJUI employs topical sections, and is in full colour, making it easier to browse or search for something specific.