An Open Phase II Clinical Trial of Fermented Wheat Germ Extract in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Response rate in 16 weeks.
研究概览
简要总结
We propose in this study to treat hormone refractory prostate cancer (HRPC) patients., with a novel preparation of fermented wheat germ nutriment (FWGE), in combination with the 1st line hormone therapy, the gonadotropin releasing hormone (GnRH), which stopped being effective. The study will be conducted during two years with 60 patients. The efficacy will be assessed in terms of clinical and serological response and by specific questionnaires.
This concept is based on previous reports regarding other diseases such as colon cancer, where the addition of a new drug to a drug which previously had failed, improved the patients' survival, the quality of life and the clinical parameters. In addition, preclinical data have shown activity of that regimen in prostate cancer cell lines and in animals' models.
FWGE exhibits a wide variety of mode of actions, in a wide range of malignant tumors. It increased the natural immune responses while decreasing the systemic inflammation often present in cancer patients. It reduced the growth of human prostate tumor xenograft in mice and prolonged their survival. It delayed disease progression, increased overall survivals, improve quality of life and reduce oxidative stress.
The long-term goal of this research is that the addition of FWGE to a drug which previously had failed, would slow down disease progression in patients with advanced and thus refractory cancers, improving the patients' quality of life, their clinical parameters and survival.
详细描述
Background and Significance
- The challenge:
Prostate cancer is a major worldwide health problem and is the most frequently diagnosed malignancy in men today. In the United States prostate cancer is the most common malignancy found in men accounting for more than 29% of all diagnosed cancer and approximately 13% of all cancer deaths. Nearly one in six men will be diagnosed with the disease at some time in their lives. In 2003 alone, an estimated 221,000 men in the United States were diagnosed with prostate cancer. In 1999, 37,000 deaths were attributed to prostate cancer in the United States, and in 2003 more than 28,000 died of the disease. Hormone-refractory prostate cancer (HRPC) is one of the most aggressive cancers. It is the second ranking cause of cancer-related deaths. Patients with localized disease have the option of radiation therapy or radical prostatectomy as definitive treatment modalities for curing the disease. However the cancer recurs in its metastatic form in 20-30% of these patients. In addition, approximately 10 % of patients diagnosed with the disease already have distant metastases, making localized therapy irrelevant. The primary treatment for the advanced state of prostate cancer is androgen deprivation therapy, to inhibit the testosterone production that facilitates prostate tumor growth. Androgen deprivation therapy is administered either by surgical castration or by medications that block testosterone production. While this treatment is effective in 85%-95% of patients, the response time lasts approximately for 12 -24 months, after which the cancer progresses to its androgen-insensitive stage. The androgen independent prostate cancer cells progress to metastatic disease. Limited treatment options exist for the hormone refractory prostate cancer (HRPC) patient, and median survival time rarely exceeds one year.
Once androgen independence has occurred, conventional chemotherapy for the treatment of metastatic cancer has shown limited activity in patients in addition to causing toxic side effects. While new chemotherapeutic regimens and hormonal agents are being tested, the survival and quality of life of these HRPC patients remains low. 2. The innovation:
We propose to treat progressing HRPC patients with a novel combination of 1st line of hormone therapy (GnRH analogues) with the non-toxic dietary supplement fermented wheat germ nutriment (FWGE). This suggestion is based on preclinical data showing activity of the regimen in prostate cancer cell lines and in animal models. Furthermore, there are previous reports regarding other diseases such as colon cancer, where the addition of a new treatment to a therapy which had previously failed, improved patient survival, quality of life and the clinical parameters.
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
- 否
入选标准
- •Histology/cytology diagnosis of prostate cancer
- •Measurable disease as identified by tumor imaging (e.g. CT, MRI) or PSA values greater than 1.5 ng/ml, and rising in 3 consecutive measurements.
- •failure of 1st line hormone therapy (GnRH analogues)
- •ECOG performance status 0-2
排除标准
- •Concurrent use of systemic anti-neoplastic therapy
- •Patients who had received systemic chemotherapy for prostate cancer.
- •Patients receiving an investigational agent within the past 30 days of study entry.
- •Patients with evidence of circumstances that are likely to interfere with the absorption of orally administrated products.
- •patients with co-morbidities considered to potentially influence the outcome of treatment in the judgment of the investigator (life-threatening diseases such as heart failure)
- •ECOG performance status > 2
结局指标
主要结局
Response rate in 16 weeks.
时间窗: 1 year
次要结局
- Quality of life in 16 weeks(1 year)