Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Prostate-specific Antigen (PSA)
研究概览
简要总结
The purpose of this study is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with localized prostate cancer prior to radical prostatectomy.
详细描述
This is a parallel group, double-blind, randomized clinical trial with two arms. The primary aim is to assess the efficacy of Fermented Soy vs. placebo in 72 adults with prostate cancer. This study has 1 primary aim and 3 (1a thru 1c) sub aims. Aim 1 is to assess the effect of Fermented Soy (QC) on PSA (prostate specific antigen) In parallel, in Aims 1a-1c will assess tumor-specific effects of QC:
Aim 1a: Identifying the anti-tumor effects of QC. This will be done by culturing multiple human cancer cell lines with QC at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence.
Aim 1b: Identify a hierarchy of tumors that are responsive to QC. From the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects.
Aim 1c: Investigate the signaling pathways in tumor cells that are modified by QC. To do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include P53 and P21 activation pathways.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically verified Prostate Cancer (at any stage)
- •Scheduled to be treated by radical prostatectomy within the next 4-10 weeks
- •Understanding and willingness to provide consent
排除标准
- •Previous (within 6 months of enrollment) or concurrent hormonal therapy or chemotherapy; specifically, treatment with 5-alpha reductase inhibitors (finasteride and dutasteride)
- •History of hormone dependent malignancies
- •Concomitant thyroid disease or currently taking thyroid hormone replacement medication
- •Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits
- •Current or past history of any liver or pancreas disease
- •History of allergy or hypersensitivity to soy-containing products
- •Malabsorption conditions that might interfere with absorption of the investigational product
研究组 & 干预措施
Intervention
Daily Fermented Soy (two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
干预措施: Fermented Soy (Drug)
Placebo
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
干预措施: Placebo (Other)
结局指标
主要结局
Prostate-specific Antigen (PSA)
时间窗: Greater than or equal to 4 weeks (up to 10 weeks)
The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The PSA range of scores and interpretation are as follows: Normal PSA Levels: 0 - 4 ng/mL, Slightly Elevated PSA: 4 - 10 ng/mL, Moderately Elevated PSA: 10 - 20 ng/mL, Highly Elevated PSA: 20+ ng/mL. Interpretation of these scores is also based on the age of the inidividual.
次要结局
- Gleason Score(Greater than or equal to 4 weeks (up to 10 weeks))
- PCa Tissue Telomeric DNA Length(Greater than or equal to 4 weeks (up to 10 weeks))
- Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change(Baseline to final visit (up to 10 weeks))
- Cell Cycle Progression Score(Greater than or equal to 4 weeks (up to 10 weeks))
- Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)(Greater than or equal to 4 weeks (up to 10 weeks))