Nutrition and Prostate Cancer
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | November 21, 2018 |
| End Date: | May 2021 |
Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
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.
with localized prostate cancer prior to radical prostatectomy.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Currently taking oral anticoagulants (other than aspirin, NSAIDS): Coumadin,
dabigatran, rivaroxaban, apixaban, edoxaban) or parenteral injection of low molecular
weight heparin (enoxaparin)
- 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
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