NCT02280356已完成2 期
Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
- •Pathologically-proven diagnosis of prostate adenocarcinoma
- •PSA 10-20ng/mL or
- •Gleason =7 or
- •Clinical stage T2b/c
- •Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
- •Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
- •International Prostate Symptom Score ≤15
排除标准
- •Prior prostate surgery (including TURP)
- •Prior history of chronic prostatitis or urethral stricture
- •Inflammatory bowel disease
- •Prior history of pelvic radiotherapy
- •Unable to give informed consent
- •Metastatic disease.
结局指标
主要结局
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
时间窗: 12 months
Participants with Urinary Toxicity Assessed by CTCAE v4.0 at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.
次要结局
- Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months(12 months)
研究者
研究点 (10)
Loading locations...
相似试验
招募中
2 期
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer PatientsRadiotherapy Side EffectBreast CancerNCT05762900Cancer Institute and Hospital, Chinese Academy of Medical Sciences65
已完成
1 期
Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)Prostate CancerNCT03269422Memorial Sloan Kettering Cancer Center35
招募中
不适用
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate CancerProstate AdenocarcinomaLocalized Prostate CarcinomaProstate CancerNCT06518226UMC Utrecht160
招募中
不适用
Radical Hypofractionated Radiotherapy for Localized Prostate CancerLocalized Prostate CancerNCT06325774Changhai Hospital20
已完成
1 期
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate CancerAdenocarcinomaProstate CancerNCT00911118Memorial Sloan Kettering Cancer Center120