Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
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
- 3-yr bNED survival
研究概览
简要总结
This is a prospective, open, randomized phase II trial.
详细描述
Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Subjects who meet all study eligibility criteria will be randomly assigned in a 1:1 ratio.
Randomization is centralized at the promoter and takes place according to a specific procedure (in attachment).
The randomization schedule will be generated by an independent group of the promoter.
Patient study number and result of randomization will be given immediately by email.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 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
- •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
研究组 & 干预措施
arm 2
SBRT along with short course (6 months) androgen deprivation (STAD)
干预措施: Decapeptyl (Drug)
结局指标
主要结局
3-yr bNED survival
时间窗: 3 years
The primary objective of the study is 3-yr 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.
次要结局
未报告次要终点
研究者
Giuseppe Sanguineti
Professore
Regina Elena Cancer Institute