CTIS2022-501551-90-00招募中1 期
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial - CTO21042GZA
Gasthuiszusters Antwerpen0 个研究点目标入组 493 人开始时间: 2023年7月4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
- 493
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
- •Histopathology-proven PCa, High-risk disease as any of the following factors: PSA > 20 ng/mL or T-stage 3 or 4 or Gleason score 8-10, An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1, Willingness to undergo a PSMA PET/ CT with or without contrast., Willingness to have their primary tumor sequenced for determination of Decipher score, Willingness to undergo SOC RT and long-term ADT (treatment with darolutamide and/ or LHRHA)
排除标准
- •Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e., bone scan, CT scan, MRI), PCa with predominant non-adenocarcinoma features (sarcomatoid or spindle or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma), Prior pelvic radiotherapy, Prior local therapy for PCa, Prior systemic therapy for PCa
研究者
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