2024-511886-12-00招募中2 期
Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II Study
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 3
- 主要终点
- The primary objective of the study is 3-yr bNED survival.
研究概览
简要总结
the primary objective of the study is 3-year bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate adenocarcinoma - IR or HR in the NCCN definition - N0M0 at staging with choline or (preferably) PSMA PET-CT; - ECOG performance status between 0 and 2;
排除标准
- •T3b disease according to the 8th AJCC classification; - PSA>20 ng/ml at any time point - Gleason Score of 9 or 10 (Grade Grouping V) - Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) - Previous radiotherapy to the pelvis - Previous chemotherapy for malignancy in past 5 years - Impossibility to implant fiducials for tracking purposes - Impossibility to undergo MRI of the prostate - Contraindication to short term AD - Prostate volume >90cc
结局指标
主要结局
The primary objective of the study is 3-yr bNED survival.
The primary objective of the study is 3-yr bNED survival.
次要结局
- Overall survival
研究者
Dott. Massimo Zeuli
Scientific
I.F.O. Istituti Fisioterapici Ospitalieri
研究点 (3)
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