NCT01488968终止不适用
A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
研究概览
简要总结
Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patient is 18 years of age or older
- •Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
- •Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
- •No clinical or radiological evidence of nodal or distant metastasis(es).
- •In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
- •Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
- •No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
- •No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
- •No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%.
- •Patient signed informed consent.
排除标准
- 未提供
研究组 & 干预措施
Standard
Active Comparator
Standard Radiation Treatment
干预措施: Standard Radiation Treatment (Radiation)
Hypofractionated
Experimental
Hypofractionated
干预措施: Hypofractionated radiation treatment (Radiation)
结局指标
主要结局
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
时间窗: 5 years
次要结局
- The biochemical control (freedom from PSA failure) rate(10 years)
- Disease free survival(10 years)
研究者
研究点 (1)
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