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临床试验 NCT06409910 (AMPORA) 针对Post-Operative Prostate Cancer目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer (AMPORA) II期 204 随机化
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临床试验NCT06409910 (AMPORA)旨在研究治疗，主要针对Post-Operative Prostate Cancer。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2024年11月26日，计划招募204名患者。该研究由University Health Network, Toronto主导，预计于2030年11月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月23日。
简要概括
This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
官方标题
A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
疾病
Post-Operative Prostate Cancer其他研究标识符
- AMPORA
- 23-5813
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Arm 1: Moderately Hypofractionated Radiotherapy External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily. | 放疗 Non-institutional-standard radiotherapy |
实验性Arm 2: Ultrahypofractionated Radiotherapy External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days. | 放疗 Non-institutional-standard radiotherapy |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Rates of Acute Toxicity | Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0) | 2 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Rates of Acute and Late Toxicity | Acute grade ≥2 genitourinary toxicity (CTCAE v5.0) | 2 years |
Quality of Life Outcomes | EPIC-26 Questionnaire | 2 years |
Quality of Life Outcomes | IPSS Questionnaire | 2 years |
Biochemical disease-free survival | Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer | 2 years |
Disease Control Rate | Radiographic and/or histopathological disease control rate | 2 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
男性
- Age >/= 18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- ECOG performance status 0-1
- Previous radical prostatectomy > 6 months prior to radiotherapy start date
- Planned to receive post-operative radiation
- Prior pelvic radiotherapy
- Contraindications to radiotherapy
- Confirmed metastases (if scan has been done for clinical care)
- Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
University Health Network, TorontoTOLMAR PHARMACEUTIQUES CANADA, INC.研究中心联系人
联系人: Andrew McPartlin, MBChB, 416-946-4501, [email protected]
2 位于 1 个国家/地区的研究中心
Ontario
London Health Sciences Centre, London, Ontario, N6A 5W9, Canada
Joelle Helou, MD, 联系人, 519-685-8650, [email protected]
招募中
University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2C1, Canada
Andrew McPartlin, 联系人, 416-946-4501, [email protected]
招募中