Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating HDR Brachytherapy: Single Institution Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- occurrence of Grade ≥3 early GU toxicity
研究概览
简要总结
Feasibility trial of twice high dose radiotherapy using Tomotherapy in patients with organ confined Prostate Cancer histologically proven. The study involves 2 steps:
A) Assessment of safety as proportion of patients with acute ≥G3 Genito-urinary (GU) and Gastro-intestinal (GI) side effects on the first 16 enrolled patients; B) evaluation of primary and secondary objectives on overall patients.
详细描述
Twice High dose external beam Radiotherapy by Image-guided tomotherapy for organ-confined Prostate cancer treatment emulating HDR brachytherapy:
Feasibility trial of twice high dose radiotherapy using Tomotherapy in patients with organ confined Prostate Cancer histologically proven. The study involves 2 steps:
A) Assessment of safety as proportion of patients with acute ≥G3 Genito-urinary (GU) and Gastro-intestinal (GI) side effects on the first 16 enrolled patients; B) evaluation of primary and secondary objectives on overall patients. Thirty-one patients will be enrolled, with histologically confirmed very low , low and intermediate risk prostate cancer following the National Comprehensive Cancer Network (NCCN) risk categories guidelines. Patient should not be eligible to prostatectomy or patient's should refuse to undergo surgery.
Prescription dose to the target: 20-23 Gy in 2 fractions on the whole prostate gland +/- seminal vesicles and 24-27 Gy in 2 fractions as simultaneous integrated boost (SIB) on the dominant intraprostatic lesion (DIL) 2 weeks in all.
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 adenocarcinoma (a diagnostic biopsy with at least 10 cores is needed)
- •Low and intermediate-risk NCCN risk categories: low-risk ( cT1-2a, Gleason Score ≤ 6 PSA <10 ng/ml) and among those with intermediate-risk features (clinical stage T2b-c or GS 7 or PSA 10-20 ng/ml) those patients with favorable ones (a single factor for intermediate risk and GLS 3 + 4 and <50% of biopsy cores containing cancer) will be selected. (30).
- •Age ≥18 years
- •Good performance status , Eastern Cooperative Oncology Group (ECOG) < 2) or Karnofsky performance status (KPS) > 70
- •No previous pelvic RT
- •Patient not eligible to prostatectomy or patient's refusal to undergo surgery.
- •NO previous prostatectomy or TURP
- •Good urinary flow (peak flow ≥ 10 ml/s)
- •Previous ADT is permitted
- •Prostate size ≤ 60 cc
- •International Prostate Symptom Score ≤ 15
- •Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Nodal involvement or distant metastases (cN1 or cM1)
- •Extracapsular tumor or locally advanced disease (cT3-cT4)
- •IPSS questionnaire > 20
- •Concomitant inflammatory bowel
- •Prior history of chronic prostatitis
- •Prior history of urethral stricture
- •Important systemic diseases or oral anticoagulant therapy ongoing
- •Non-conformity to dose constraints at the treatment planning
- •Other invasive cancer (apart from non-melanoma skin), unless the patient has been free from disease for at least 3 years;
- •Abnormal complete blood count. Any of the following: platelet count less than 75,000/ml, Hb level less than 10 gm/dl, WBC less than 3.5/ml, abnormal renal function tests (creatinine > 1.5), severe renal impairment (GFR less than 30)
- •Placement of pacemakers and metallic vascular clips (all contraindication to performing prostate mpMRI).
结局指标
主要结局
occurrence of Grade ≥3 early GU toxicity
时间窗: within 3 months after end of Radiotherapy
Early Grade ≥3 GU toxicity measured by Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scale, using a scoring range from 0 to 5 for, where 0 means an absence of radiation effects and 5 means the effects led to death
occurrence of Grade ≥3 early GI toxicity
时间窗: within 3 months after end of Radiotherapy
Early Grade ≥3 GI toxicity measured by Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scale, using a scoring range from 0 to 5 for, where 0 means an absence of radiation effects and 5 means the effects led to death
次要结局
- Quality of Life (QoL)(before treatment, at 12 and 24 months of follow up)
- Quality of urinary function(before treatment, at 3, 6, 12 and 24 months of follow up)
- Evaluation of Prostate Antigen Serum (PSA) failure(up to 8 years)
- Occurrence of Grade ≥3 Late GU toxicity(more than 6 months after end of Radiotherapy)
- Time to biochemical failure (TTBF)(up to 8 years)
- Overall Survival (OS)(up to 8 years)
- Time to progression (TTP)(up to 8 years)
- Quality of erectile function(before treatment, at 3, 6, 12 and 24 months of follow up)