Nutrition and Prostate Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03532308

Run by

Yale University

People needed

19

Starts

2018-11-21

Expected to finish

2019-12-14

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States
• Yale New Haven Health- Lawrence + Memorial Hospital — New London, Connecticut, United States
• South County Hospital — Wakefield, Rhode Island, United States

Full record on ClinicalTrials.gov

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