González San Segundo C, López-Campos F, Gómez Iturriaga A, Santos M, Ocanto A, Montezuma L, Boladeras-Inglada A M, Glaria L, Guardado S, Rodríguez A, Henríquez I, Olivera J, Duque-Santana V, Garre J, Moreno S, Valero J, Conde A J, Doval A, Sancho G, Martin Nieto P, Castaño Cantos A, García N, Fernández Alonso S, García García R, Díaz Gavela A, Buchser D, Maldonado X, Mases J, Hernando Requejo O, Sanmamed N, Martínez Salamanca J I, Couñago F
Servicio de Oncología Radioterápica, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Servicio de Oncología Radioterápica, Hospital Universitario Ramón y Cajal, Madrid, Spain; Servicio de Oncología Radioterápica GenesisCare, Hospital Universitario San Francisco de Asís, Madrid, Spain; Servicio de Oncología Radioterápica GenesisCare, Hospital Universitario La Milagrosa, Madrid, Spain.
Actas Urol Esp (Engl Ed). 2025 Sep;49(7):501823. doi: 10.1016/j.acuroe.2025.501823. Epub 2025 Jul 31.
URONCOR 06-24 (NCT05781217) is a prospective, multicenter, randomized, open-label, phase III trial evaluating the impact on distant metastasis-free survival (MFS) of short-term (6 months) versus long-term (24 months) androgen deprivation therapy (ADT) in combination with salvage radiotherapy in high- and intermediate-risk patients after biochemical recurrence (BCR).
A total of 534 men will be randomized to receive either 6 or 24 months of ADT. Stratification is based on risk group (intermediate vs high) and nodal status (pN0 vs pNx).
From March 2023 to November 2024, 122 patients have been enrolled: 34 (28%) with intermediate risk and 88 (72%) with high risk. Fifty-five patients (45%) are pNx. The mean time from surgery to BCR is 25.4 months, and the PSA at inclusion was 0.55 ng/ml. Restaging was performed in 89 patients, 75 of whom underwent PET/CT (97%, PSMA PET/CT). Hypofractionation was used in 68% of cases, and elective pelvic irradiation in 33%. At the time of analysis, all patients had PSA normalization. No severe ADT-related toxicity has been reported.
URONCOR 06-24 is the first clinical trial comparing long- versus short-term ADT in the setting of BCR after prostatectomy, with stratification by risk group. Initial recruitment data show a balanced distribution of prognostic factors between both arms and no serious adverse events related to ADT.
URONCOR 06 - 24（NCT05781217）是一项前瞻性、多中心、随机、开放标签的III期试验，旨在评估短期（6个月）与长期（24个月）雄激素剥夺疗法（ADT）联合挽救性放疗对生化复发（BCR）后高风险和中风险患者远处无转移生存期（MFS）的影响。
总共534名男性将被随机分配接受6个月或24个月的ADT。分层基于风险组（中风险与高风险）和淋巴结状态（pN0与pNx）。
从2023年3月至2024年11月，已招募122名患者：34名（28%）为中风险，88名（72%）为高风险。55名患者（45%）为pNx。从手术到BCR的平均时间为25.4个月，纳入时的前列腺特异性抗原（PSA）为0.55 ng/ml。89名患者进行了重新分期，其中75名接受了正电子发射断层扫描/计算机断层扫描（PET/CT，97%为前列腺特异性膜抗原PET/CT）。68%的病例采用了大分割放疗，33%采用了选择性盆腔照射。在分析时，所有患者的PSA均已恢复正常。尚未报告严重的与ADT相关的毒性反应。
URONCOR 06 - 24是第一项在前列腺切除术后BCR情况下比较长期与短期ADT的临床试验，并按风险组进行分层。初步招募数据显示两组之间预后因素分布均衡，且未出现与ADT相关的严重不良事件。
