NCT05183074招募中不适用
Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
- To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer
- To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT
- To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci
- To investigate the relationship between the changes of blood and tissue biomarkers and manifestations on mp-MRI pre-/post-MRL-SBRT, to further ascertain the predictive factors of local persisting and/or relapse disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years。
- •Histology confirmed prostate cancer.
- •Risk stratification, localised disease including patients with low-risk(cT1-T2a，PSA <10ng/mL，Gleason score≤6) who refuse active surveillance, favorable or unfavorable intermediate-risk and selected high-risk(cT2b-T3a or minimally T3b，PSA 10-40ng/mL，Gleason score 7-8) disease.
- •Oligo-metastatic disease including patients with prostate in-situ and oligometastatic disease (no limit to mets number and organs, with all metastatic foci can be safely treated by radical SBRT dose)
- •Postate gland volume ≤100cc
- •IPSS score of <18
- •Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
排除标准
- •Contraindications to MRI.
- •TURP within the past 6 months
- •Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
- •Previous pelvic irradiation
- •Refuse contraception
结局指标
主要结局
The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: Three months post-MRL-SBRT
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(6-months, 1-year and 2-year)
- Quality of life evaluation(Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter)
- Biochemical-relapse free survival(2-year)
研究者
NINGNING LU
Principle Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal TumorMediastinal TumorNCT05163509Sun Yat-sen University59
进行中（未招募）
不适用
Bony M - Stereotactic Ablative Radiotherapy (SABR) of Bony Metastases in Patients With Oligometastatic DiseaseOligometastatic DiseaseBone MetastasesStereotactic Body RadiotherapyNCT05101824Gitte Fredberg Persson MD PhD67
招募中
不适用
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal CancerAbdominal CancerNCT06604533Australasian Gastro-Intestinal Trials Group30
Unknown
不适用
SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue MetastasesSolid TumorOligometastasesSoft Tissue DiseaseNCT04407897Herlev Hospital121
Unknown
2 期
Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLCNon-Small Cell Lung CancerNCT02584699Luhua Wang40