NCT03938649进行中（未招募）2 期
Randomized Phase II Study of Combination Androgen Deprivation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer: Stereotactic Body Radiotherapy vs conventionAl IMRT to Prostate and Pelvic Nodes (SRAM Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- CCTU
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare acute toxicities between SBRT and conventional IMRT
研究概览
简要总结
This is a phase 2 randomized study for High risk localized prostate cancer (T3 to T4 disease and/or PSA > 20 and/or Gleason score ≥ 8) without evidence of distant and nodal metastasis.
Patient will be randomized to:Arm 1
- Conventional IMRT RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes).
- 38 fractions of daily treatment, Monday to Friday
or Arm 2
SBRT
- RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes)
- 5 fractions of weekly treatment. Once fraction per week. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy (detail as below)
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
- 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
- •Histological confirmation of prostate adenocarcinoma
- •High risk prostate cancer patients (i.e. T3 to T4 disease and/or PSA > 20 and/or Gleason score ≥ 8)
- •ECOG performance score 0-1
- •History/physical examination within 2 weeks prior to registration
- •Able to sign informed-consent
排除标准
- •Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
- •Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g. DES), or surgical castration (orchiectomy)
- •Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Patients who have received prior chemotherapy.
研究组 & 干预措施
Conventional IMRT
Experimental
- RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes).
- 38 fractions of daily treatment, Monday to Friday
干预措施: Conventional IMRT (Radiation)
SBRT
Experimental
- RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes)
- 5 fractions of weekly treatment. Once fraction per week.
干预措施: SBRT (Drug)
结局指标
主要结局
To compare acute toxicities between SBRT and conventional IMRT
时间窗: 4 years
Toxicities will be assessed by AE CTC version 4 between 2 treatment arms
次要结局
- To compare the progression-free survival at 5 years(5 years)
- To compare the overall survival at 5 years(5 years)
- To compare the late toxicities between 2 treatment arms(5 years)
- To compare health-related quality of life (HRQOL) between SBRT and conventional IMRT(4 years)
- To compare the biochemical-failure free survival at 5 years(5 years)
研究者
CCTU
Comprehensive Clinical Trial Unit
Chinese University of Hong Kong
研究点 (1)
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