Clinical trial NCT03532308: Nutrition and Prostate Cancer
Official title: Assessing the Clinical Response of Prostate Cancer to a Fermented Soy Extract
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Fermented Soy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Prostate-specific Antigen (PSA)
timeFrame: Greater than or equal to 4 weeks (up to 10 weeks)
Secondary outcomes:
measure: Gleason Score
timeFrame: Greater than or equal to 4 weeks (up to 10 weeks)
measure: PCa Tissue Telomeric DNA Length
timeFrame: Greater than or equal to 4 weeks (up to 10 weeks)
measure: Cancer of the Prostate Risk Assessment (CAPRA-S) Score Change
timeFrame: Baseline to final visit (up to 10 weeks)
measure: Cell Cycle Progression Score
timeFrame: Greater than or equal to 4 weeks (up to 10 weeks)
measure: Functional Assessment of Cancer Therapy - Prostate (FACT-P v4©)
timeFrame: Greater than or equal to 4 weeks (up to 10 weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: New London
country: United States
facility: Yale New Haven Health- Lawrence + Memorial Hospital
state: Connecticut
city: Wakefield
country: United States
facility: South County Hospital
state: Rhode Island
Study officials:
References: