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临床试验/NCT00956228
NCT00956228已完成1 期

Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
72
试验地点
1
主要终点
It is expected between 0 and 9% of patients will have grade 3 or 4 toxicity.

研究概览

简要总结

The current study involves a novel and aggressive therapeutic approach for patients' prostate cancer. In addition, the investigators propose to administer hormonal therapy to patients with an especially high risk: those with initial Gleason scores of > 6, PSA > 10 ng/ml, T3/T4 primary tumors, and those found to be node positive (N+). The use of hormonal therapy in these specific settings correlates with our current standard of care. IMRT is better able to spare and protect normal tissues from receiving radiation than 3-D conformal RT. The radiotherapy would be followed by continued hormonal therapy for a total of 6 months in those who have one of the following Gleason 7 and PSA 10-20 and as per the previous version of this trial, 1 year similar to that delivered by the EORTC for higher risk patients, (those with initial Gleason scores of > 8, PSA > 20 ng/ml, or T3/T4 tumors). Those found to be N(+) would have the hormonal therapy continued indefinitely or until disease progression occurred in a manner analogous to the Messing et. al. series in prostatectomy patients. The goals are to develop and administer a program of treatment that includes the most recent developments in imaging, integrating data from both the CT scan and the ProstaScint scan to optimize prostate cancer RT. The CT scan will be used for staging and to determine the exact location of the entire prostate which will receive a reasonable dose of RT. The ProstaScint will be used to assess the spread of disease to lymph nodes as well as to determine the exact location of the tumor within the prostate gland. This region will then be boosted to a tumorcidal dose. The investigators then plan to monitor the toxicity and outcome of this treatment. The investigators expect that this program of radioimmunoguided IMRT will likely result in similar or less toxicity and increased cure rates when compared to conventional radiotherapy and standard IMRT programs.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • Patients with pathologically proven prostate cancer
  • No evidence of distant metastases (M0) on physical examination, bone scan
  • ECOG PS 0,1,2
  • Adequate organ function as evidenced by:
  • Hemoglobin > 10.0 gm/dl
  • White blood count > 3000/mcL
  • Platelet count > 90,000/mcL
  • AST < 2x normal
  • Age > 18 years
  • Patients can not be allergic to Leuprolide or Goserelin if the pretreatment PSA > 20, Gleason Score > 8, T3/4, or N1 disease
  • Written informed consent
  • We anticipate enrolling at least 50 patients per year, which would bring accrual to projected total of 100 patients in 2 years

排除标准

  • 未提供

结局指标

主要结局

It is expected between 0 and 9% of patients will have grade 3 or 4 toxicity.

The primary outcome will be assessment of toxicity as well as efficacy as determined by survival rates, freedom from biochemical relapse rates, local control rates, distant failure rates.

The main endpoint of the toxicity component is evaluating how many patients develop grade 3 or greater toxicity.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (1)

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