Prospective Phase III Randomized Trial of Prostate Only or Whole Pelvic RadioTherapy in High Risk Prostate Cancer (POP-RT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Biochemical Disease Free Survival
研究概览
简要总结
Evidence to justify the use of the pelvic field is lacking for men with high risk localized prostate cancer. An additional randomized study is needed in men with a potential risk of nodal involvement to test the hypothesis that the use of the pelvic field contributed to the benefit observed in those studies.
This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in patients with High risk, non metastatic Prostate cancer with a Lymph nodal >20% with Primary 5 year Biochemical failure free survival and Secondary Disease free survival, overall survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2 an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at rectal-prostate interface will receive 64 Gy/25#.
All patients will receive hormone therapy starting at least 8 weeks prior to the beginning of radiotherapy. They will continue the hormone therapy and later for a total duration of 2-3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Any age according to the fitness estimated by the Physician
- •Physician estimated life expectancy > 5 years
- •Biopsy proven Adenocarcinoma of prostate
- •High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases ≥ 20% as per the Roach formula (2/3 PSA) + [(GS - 6) x 10] If Gleason Score 8-10 - Any PSA, T1- T3a N0 M0 If Gleason Score 7 - PSA > 15, T1-T3a N0 M0 If Gleason Score 6 - PSA > 30, T1-T3a N0 M0 T3b-T4a N0 M0, Any Gleason Score, Any PSA
- •Ability to receive long term hormone therapy/ Orchidectomy
- •KPS ≥ 70 (see appendix)
- •Estimated life expectancy > 5 years
- •No previous history of malignancy ≤5 years
- •No prior history of therapeutic irradiation to pelvis
- •Patient willing and reliable for follow-up and QOL
- •No major co morbidities preventing radical treatment
- •Signed study specific consent form
- •Any histopathology other than Adenocarcinoma
- •Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
- •No prior history of pelvic surgery
- •Uncontrolled diabetes
- •Uncontrolled cardiac co morbidity
- •Presence of nodal or distant metastatic disease
排除标准
- 未提供
研究组 & 干预措施
Prostate Only
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV
干预措施: IGRT (Radiation)
Whole Pelvis
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV and 50 Gy in 25 fractions to nodal region .
干预措施: IGRT (Radiation)
结局指标
主要结局
Biochemical Disease Free Survival
时间窗: 5 years
Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA\>2ng/ml over the nadir PSA
次要结局
未报告次要终点
研究者
Dr Vedang Murthy
Dr Vedang Murthy
Tata Memorial Centre