NCT04984343进行中（未招募）2 期
Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
研究概览
简要总结
The study is a randomized study that compares 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk prostate cancer.
详细描述
This study is a randomized non-inferiority trial comparing 5 to 2 radiotherapy treatments using an MRI linear accelerator for men with low or intermediate-risk prostate cancer electing for definitive radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Men aged >=18 with histologically confirmed low or intermediate risk prostate cancer per NCCN guidelines.
- •ECOG 0 - 1
- •IPSS < 18
- •Ability to receive MRI-guided radiotherapy.
- •Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
- •Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.
排除标准
- •Prior history of receiving pelvic radiotherapy.
- •Patient with history of inflammatory bowel disease.
- •MRI Prostate Volume > 80 cc
- •MRI Stage > T3a
- •Unilateral or bilateral hip replacements.
- •History of bladder neck or urethral stricture.
- •TURP < 8 weeks prior to radiotherapy
- •Metastatic (pelvic nodal or distant) disease on CT, Bone, Fluciclovine, and/or PSMA PET scan
结局指标
主要结局
Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
时间窗: Baseline, 24 months
The primary objective is to demonstrate that 2 treatments of radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms compared to 5 treatments of radiotherapy 2 years after treatment completion.
次要结局
- Change in the number of patient reported GI symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)(Baseline, 1 week , 3months, 6 months, 12 months and 60 months)
- Change in the number of patient reported sexual symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)(Baseline, 1 week, 3months, 6 months, 12 months and 60 months)
- Time to Progression (TTP)(60 months)
- Change in the number of patient reported GU symptoms at specific intervals as measured by Expanded Prostate Cancer Index Composite (EPIC)(Baseline, 1 week, 3months, 6 months, 12 months and 60 months)
- Compare Overall Survival Rates(60 months)
- prostate cancer specific survival(60 months)
研究者
研究点 (4)
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