短期与长期雄激素剥夺联合挽救性放疗治疗根治性前列腺切除术后生化失败的随机试验:URONCOR 06-24。
A randomised trial of short- vs long-term androgen deprivation with salvage radiotherapy for biochemical failure following radical prostatectomy: URONCOR 06-24.
发表日期:2024 Jul 23
作者:
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
来源:
BJU INTERNATIONAL
摘要:
挽救性放疗(SRT)和雄激素剥夺疗法(ADT)在常规临床实践中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,对于 ADT 的最佳持续时间尚无护理标准共识。研究人员提出将接受 SRT 治疗的前列腺癌患者分为三个不同的风险组,以便更好地定义 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、III 期临床试验。该试验的目的是确定短期(6个月)与长期(24个月)ADT联合SRT对RP后BCR前列腺癌患者无远处转移生存期(MFS)的影响。主要终点是接受长期 ADT 与短期 ADT 联合 SRT 治疗的前列腺癌患者的 5 年 MFS 率。次要目标是生化无复发间隔、盆腔无进展生存期、开始全身治疗的时间、去势抵抗时间、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。总共 534 名患者将按 1:1 随机分配至 ADT 6 个月或 ADT 24 个月,采用黄体生成素释放激素类似物联合 SRT,按风险组和病理淋巴结状态分层。该研究是在世界医学协会宣言的指导原则下进行的赫尔辛基。结果将在研究会议和同行评审期刊上传播。EudraCT 编号 2021-006975-41。© 2024 BJU International。
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.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).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.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.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.EudraCT number 2021-006975-41.© 2024 BJU International.