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临床试验/NCT03889119
NCT03889119进行中(未招募)不适用

Stereotactic Body Radiation Therapy (SBRT) for the Management of Carcinoma of the Prostate: Quality of Life Data After Primary Stereotactic Body Radiation Therapy for Localized Prostate Cancer

Hoag Memorial Hospital Presbyterian2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
2
主要终点
The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.

研究概览

简要总结

The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.

Traditional External beam radiation therapy (EBRT) for prostate carcinoma is typically done over the course of approximately 42-45 daily treatments SBRT is a way to condense this treatment into a course of 5 treatments, delivering more dose per day.

详细描述

Prostate cancer is the most common cancer diagnosed in men, and ranks second in estimated deaths. The current standard of care for localized prostate cancer consists of observation, surgery or radiation therapy. From a radiation perspective, accepted options include external beam radiation therapy, brachytherapy, or a combination of those. Acceptable external beam radiation options are further defined as conventionally fractionated (over approximately 8-9 weeks), or moderately hypo-fractionated (over approximately 4-6 weeks).

Stereotactic body radiation therapy (SBRT) is a newer technique, allowing treatment to be delivered in an extremely hypo-fractionated regimen (i.e. in 5 fractions). Current consensus guidelines describe SBRT as "a cautious alternative to conventionally fractionated regimens at clinics with appropriate technology, physics, and clinical expertise."

The goal of any therapy is to maximize the effect of that treatment on cancer cells and minimize any effect on normal tissue. In radiation therapy, this is mainly done through dose targeting (i.e. limiting the radiation dose to the targets and minimizing dose to normal surrounding organs). Advancements in radiation therapy have allowed for better targeting, resulting in shrinking margins of treatment around cancer cells.

The therapeutic window can also be optimized through the use of fractionation (i.e. amount of dose delivered per day) in radiation therapy. Since cancerous and normal tissue cells respond differently to changes in fractionation, the therapeutic window could theoretically be improved by choosing a fractionation pattern to which cancer cells are more sensitive. Historical generalizations put cancer cells into the category of early responding tissues, which would make them more sensitive to cell death when radiation is delivered in a protracted fractionation pattern, such as over 8-9 weeks of radiation therapy.

However, studies have emerged which suggest that prostate cancer is unlike other cancers and reactive more like late responding tissues. With that in mind, prostate cancer cells could be more sensitive to high doses per fraction, which could provide a radiobiological advantage and a greater therapeutic window with the use of SBRT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate History/physical examination with digital rectal examination of the prostate
  • Histological evaluation of prostate biopsy with assignment of Gleason score to the biopsy material.
  • Clinical stage T1-3 (AJCC 7th edition).
  • Males age ≥ 18
  • Patient must be able to provide study-specific informed consent prior to study entry.
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

排除标准

  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease
  • No life expectancy restrictions will apply
  • Performance Status will not be considered

结局指标

主要结局

The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.

时间窗: 5 years

The number of patients demonstrating biochemical failure will be assessed. Biochemical failure will be defined using the Phoenix definition (Roach et al. IJROBP 2006), which is defined as a rise above nadir PSA + 2 ng/ml.

次要结局

  • The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Lin

Radiation Oncologist

Hoag Memorial Hospital Presbyterian

研究点 (2)

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