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临床试验/CTIS2023-505024-62-01
CTIS2023-505024-62-01招募中1 期

Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST) - IRA-RAD-2022-001

Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)0 个研究点目标入组 51 人开始时间: 2023年9月5日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
51

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
Male

入选标准

  • Patients with histologically prostate adenocarcinoma, confirmed with a biopsy., Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone <50 ng/ml or 1.7 nmol/L)., Radiological confirmation (with choline-PET/CT or 68Ga-PSMAPET/CT) of =5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (< 3 cm major diameter in bone metastases, < 5 cm in lymph node metastases)., Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study., Patients must provide written informed consent., Life expectancy > 3 months.

排除标准

  • Patients with prostate carcinoma with histology other than adenocarcinoma., No previous biopsy., > 5 metastasis, Patients with visceral metastasis and or metastasis non elegible to receive SBRT., Patients with Testosterone above castration levels., Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.

研究者

发起方
Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)

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