Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Acute toxicity according to CTCAE v 5.0
研究概览
简要总结
The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.
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 y
- •Histologically confirmed prostate adenocarcinoma
- •Low risk: cT1c-T2a, Gleason score 6, PSA < 10ng/mL
- •Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, < 50% positive biopsy cores)
- •Unfavorable intermediate risk: > 1 intermediate risk factor, Gleason 4+3, > 50% positive biopsy cores)
- •Limited high risk: cT3a with PSA < 40ng/mL or cT2a-c with a Gleason score > 7 and/or a PSA > 20ng/mL but < 40ng/mL
- •World Health Organization performance score 0-2
- •Written informed consent
- •Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
排除标准
- •Transurethral resection (TUR) < 3months before SBRT
- •International Prostate Symptom Score (IPSS) > 19
- •Prostate volume > 100cc on transrectal ultrasound (TRUS)
- •Stage cT3b-T4
- •N1 disease (clinically or pathologically)
- •M1 disease (clinically or pathologically)
- •PSA > 40ng/mL
- •inflammatory bowel disease
- •immunosuppressive medications
- •prior pelvic RT
- •contra-indications for MRI
结局指标
主要结局
Acute toxicity according to CTCAE v 5.0
时间窗: from the first treatment fraction up to 3 months
Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0
Acute toxicity according to RTOG criteria
时间窗: from the first treatment fraction up to 3 months
Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria
次要结局
- Late toxicity according to CTCAE v 5.0(within 5 years after start of radiotherapy)
- Freedom from biochemical failure(from start of radiotherapy until PSA relapse, assessed up to 5 years)
- Late toxicity according to RTOG criteria(within 5 years after start of radiotherapy)
- Quality of life assessment(from the start of radiotherapy until 5 years after treatment)
- IPSS quality of life(from the start of radiotherapy until 5 years after treatment)
- Overall survival(from start of radiotherapy until 5 years after treatment)
- Prostate specific quality of life assessment(from the start of radiotherapy until 5 years after treatment)
- EPIC-26 quality of life(from the start of radiotherapy until 5 years after treatment)
- Disease-free survival(from start of radiotherapy until 5 years after treatment)
研究者
Mark De Ridder
Principal Investigator
Universitair Ziekenhuis Brussel