NCT07751159招募中2 期
Balancing Radiation Intensification and Quality of Life in Higher-Risk Prostate Cancer (The BALANCE-RT Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 7
- 主要终点
- Change in International Prostate Symptom Score / IPSS at 3 months
研究概览
简要总结
The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-metastatic prostate cancer.
- •Classified as unfavorable intermediate-, high-, or very high-risk prostate cancer according to NCCN risk stratification guidelines. (Note: cT3a or T3b by MRI or PSMA PET allowed)
- •Considered by the treating radiation oncologist as a suitable candidate for both HDR brachytherapy boost and SBRT
排除标准
- 未提供
研究组 & 干预措施
Arm A: HDR Brachytherapy Boost + SBRT
Active Comparator
Standard of Care Brachytherapy/Radiation and SBRT
干预措施: SBRT (Radiation)
Arm B: SBRT Alone
Experimental
SBRT alone
干预措施: SBRT (Radiation)
Arm A: HDR Brachytherapy Boost + SBRT
Active Comparator
Standard of Care Brachytherapy/Radiation and SBRT
干预措施: Standard of Care HDR Brachytherapy (Radiation)
结局指标
主要结局
Change in International Prostate Symptom Score / IPSS at 3 months
时间窗: 3 months
Change in International Prostate Symptom Score / IPSS to measure if SBRT alone results in less acute patient reported urinary symptoms measured by IPSS at 3 months than HDR brachytherapy boost combined with SBRT
次要结局
未报告次要终点
研究者
研究点 (7)
Loading locations...
相似试验
尚未招募
不适用
Understanding the Impact of Radiotherapy on Quality of Life in Breast Cancer Patients Treated at DMIHER, Sawangi (2023–2024)CTRI/2024/12/078440Datta Meghe Institute of Higher Education and Research59
招募中
3 期
Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate CancerProstate CancerNCT07548164Memorial Sloan Kettering Cancer Center224
尚未招募
2 期
Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II StudyNCT07467590Daping Hospital and the Research Institute of Surgery of the Third Military Medical University33
招募中
3 期
Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and ImmunotherapyNCT07328841Ming-Yuan Chen456
招募中
3 期
Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray TreatmentProstate CancerNCT07293585Jonsson Comprehensive Cancer Center200