背景:挽救性放疗(SRT)和雄激素剥夺治疗(ADT)在常规临床实践中被广泛用于治疗前列腺癌根治术(RP)后发生生化复发(BCR)的患者。然而,关于最佳持续时间ADT尚无标准护理共识。研究人员在接受SRT治疗的前列腺癌患者中提出了三个不同的风险组,以便更好地定义ADT联合SRT的适应症和持续时间。
方法:URONCOR06-24试验(ClinicalTrials.gov标识符NCT05781217)是一项前瞻性,多中心,随机化,开放标签,第三阶段,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后患有BCR的前列腺癌患者的无远处转移生存期(MFS)的影响(中危和高危)。
方法:主要终点是长期与短期ADT联合SRT治疗的前列腺癌患者的5年MFS率。次要目标是无生化复发间隔,盆腔无进展生存率,开始系统治疗的时间,去势抵抗的时间,癌症特异性生存率,总生存率,急性和晚期毒性,和生活质量。
方法:总共534名患者将被随机分为1:1至ADT6个月或ADT24个月,与促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。
背景:该研究是在《世界医学协会赫尔辛基宣言》的指导原则下进行的。结果将在研究会议和同行评审的期刊上传播。
背景:EudraCT编号2021-006975-41。
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.