NCT06220435招募中不适用
Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Grade 3+ Genitourinary Adverse Events
研究概览
简要总结
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.
详细描述
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.
Specific aims of the study are:
- To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome).
- To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer.
- To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.
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
- •Life expectancy >5 years
- •Age ≥18 years
- •World Health Organization (WHO) performance status 0-2
- •Histological evidence of prostate cancer
- •Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
- •At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)
- •Patients must be able to comply with the protocol
- •Signed informed consent
- •Adequate laboratory findings: haemoglobin (Hb) >90 g/L, absolute neutrophil count >1.0x10^9/l, platelets >75x10^9/l, bilirubin <2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <2.0x ULN)
排除标准
- •Regional or distant metastasis
- •Any contraindications for MRI
- •PSA >150 ng/ml
- •Previous pelvic radiotherapy
- •Prior prostate surgery including transurethral resection of the prostate (TURP)
- •Endocrine treatment (past or present)
- •Other malignancies than prostate cancer and basalioma in the past five years
- •Serious disease state that makes study inclusion and treatment unsuitable
- •Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)
研究组 & 干预措施
HYPO-RT-PC boost
Experimental
Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.
干预措施: Ultra-hypofractionated radiotherapy regimen. (Radiation)
结局指标
主要结局
Grade 3+ Genitourinary Adverse Events
时间窗: start of treatment - 5 years
Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
- Cancer-specific survival(enrollment date - 5 years)
- Overall survival failure-free survival, cancer-specific survival, and overall survival(enrollment date - 5 years)
- Failure-free survival(consent date - 5 years)
- Grade 2+ Genitourinary Adverse Events(start of treatment - 5 years)
- Biochemical failure-free survival(enrollment date - 5 years)
- Adverse Events according to CTCAE v5.0(start of treatment - 5 years)
- Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30)(inclusion date - 5 years)
- Local failure-free survival(enrollment date - 5 years)
- Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival(enrollment date - 5 years)
- Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival(enrollment date - 5 years)
- Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25)(inclusion date - 5 years)
研究者
研究点 (2)
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