Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action Between African American and Caucasian Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- Median Change in Percent Ki-67 From Baseline
研究概览
简要总结
The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.
详细描述
Patients will need to take two (2) capsules daily, one with their breakfast and one with their dinner. On the day prior or the day that patients are coming in for their pre-operative surgery blood work, we ask that they take the second dose with lunch, if their appointment is in the afternoon.
At the start of the study and at the end of the study (3-6 weeks), patients will undergo interviews, complete questionnaires, and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use.
Patients will also receive a multivitamin/mineral supplement for the 3-6 weeks that they are on this study and will be required to take one (1) every day. It is required that patients not take any other vitamin/mineral or herbal preparation containing isoflavones and avoid eating or drinking soy products.
We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks (+/- 3 days) from start of study agent. In addition to their first visit, patients will be required to come in the day of the surgery for prostatectomy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of localized prostate cancer (PCa), based on pathological assessment from biopsy specimens
- •No prior or current therapy for PCa or history of cancer except non-melanoma skin cancer
- •Scheduled for prostatectomy between 3- 6 weeks (+/-3 days) after start of study agent
- •No known history of hepatic or renal disease (LFTs (SGOT/SGPT) > 5.0 x upper limit of normal as evidenced by impairment of baseline laboratory values, Actual creatinine clearance of >60 utilizing the Cockcroft-Gault formula (1976), which employs creatinine measurements and a patient's weight to predict the clearance. The constant is 1.23 for men.
- •Omnivorous diet
- •No evidence of prostatitis or urinary tract infection
- •Able and willing to give written informed consent
- •Currently not using or willing to discontinue any nutritional supplements that contain soy or soy isoflavones
- •Not allergic to study supplements
- •Not on antibiotics
- •Men who do not consume more than 3 - 4 oz. of soy or soy products per week
- •Not taking steroid hormones or medications which have known impact on prostatic specific antigen (PSA)
- •Health status cleared by primary MD or urologist
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
排除标准
- •Prior history of prostate cancer; Current or prior history of other malignancies (exceptions include nonmelanoma skin cancer or other cancer with no evidence of tumor recurrence five years after definitive treatment)
- •History of renal or hepatic disease, including history of hepatitis B, C or delta as evidenced by impairment of baseline laboratory values
- •Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
- •History of allergic reactions attributed to soy isoflavones or other compounds of similar chemical or biologic composition to Novasoy 400® or the inactive components present in the purified isoflavone and placebo capsules
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
- •Only African American (a person having origins in any of the black racial groups of Africa) and Caucasian (a person having origins in any of the original people of Europe, Middle East, or North Africa) men, as defined by the NIH, will be included in this study. Since this is an investigation targeting men with PCa, women are not eligible for the study.
研究组 & 干预措施
Purified Isoflavones
Soy-based isoflavone concentrate with methyl cellulose blend filler. 40 mg daily.
干预措施: Purified isoflavones (Drug)
Methyl cellulose blend
Placebo.
干预措施: Methyl cellulose blend (Drug)
结局指标
主要结局
Median Change in Percent Ki-67 From Baseline
时间窗: Baseline to post intervention - up to 6 weeks
Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.
Number of Toxicity Events by Final Attribution and Treatment Arm
时间窗: Up to 6 weeks
Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.
次要结局
- Biomarkers of Disease Progression - Serum PSA(Up to 6 weeks)
- Change in Plasma Concentrations of Isoflavone(Up to 6 weeks)
- Biomarkers of Disease Progression - Estradiol(Up to 6 weeks)
- Biomarkers of Disease Progression - Free Testosterone(Up to 6 weeks)
- Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3(Up to 6 weeks)
- Biomarkers of Disease Progression - IGF-1(Up to 6 weeks)
- Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)(Up to 6 weeks)
- Biomarkers of Disease Progression - Total Testosterone(Up to 6 weeks)