Nutrition and Prostate Cancer

• Status: Terminated
• Trial end date: 2019-12-14
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University

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