Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Toxicity or Discontinuation of Therapy
研究概览
简要总结
As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. However, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. For this reason and for radiobiological considerations the total treatment time is increasingly shortened. It has been shown in several randomized phase III studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. Meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). The current, prospective, non-randomized, multicentric, Phase II SMILE study is now testing whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.
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
- •Histologically confirmed prostate carcinoma with tissue classification according to Gleason score and PSA
- •low- or intermediate-risk carcinoma according to d'Amico criteria or early high-risk Carcinoma (cT3a and / or GS ≤ 8 and / or PSA ≤ 20ng / ml)
- •IPSS (International Prostate Symptom Score) max. 12
- •Prostate volume <80cm³
- •Karnofsky index ≥ 70%
- •Age ≥ 18 years
- •Patient information provided and written consent
- •Ability of the patient to give consent
排除标准
- •Previous radiotherapy in the pelvis
- •Previous local therapy of the prostate
- •lymphogenic metastasis
- •Stage IV (distant metastases)
- •Contraindication to MRI
- •Simultaneous participation in another clinical study which could influence results of either of the respective study
研究组 & 干预措施
MR-guided Radiotherapy (5 x 7,5 Gy)
5 x 7,5 Gy prescribed on the PTV
干预措施: MR-guided Radiotherapy (Radiation)
结局指标
主要结局
Toxicity or Discontinuation of Therapy
时间窗: Within 1 Year
One of the the following events are counted as an Event (Number of Participants affected): * any urogenital or gastrointestinal grade ≥ 2 toxicity within one year after the start of RT (according to NCI CTCAE Version 5.0) * Discontinuation of therapy, with a connection to the study treatment
次要结局
- Mortality(Within 1 year and within 5 years)
- Hormone therapy-free Survival(from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant)
- bPFS(from start of radiotherapy (day 1) until PSA-relapse according to Phoenix-Criteria (Prostate-specific antigen (PSA) nadir + 2 ng/mL after radiotherapy), assessed up to 5 years)
- Quality of life according to EORTC QLQ-C30(from start of radiotherapy (day 1) until end of follow-up (up to 5 years))
- Symptoms and Toxicity(from start of radiotherapy (day 1) until end of follow-up (up to 5 years))
- Number of Toxicities(Within 1 year and within 5 years after start of radiotherapy)
- OS(from start of radiotherapy (day 1) until death or censoring assessed up to 5 years)
- Quality of life according to EORTC QLQ-PR25(from start of radiotherapy (day 1) until end of follow-up (up to 5 years))
研究者
Juergen Debus
Medical Director RadioOncology
University Hospital Heidelberg