NCT01682941

Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen

Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent cancer. PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating patients with recurrent prostate cancer or rising prostate-specific antigen

Detailed description

OBJECTIVES: I. To precisely quantify the absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites in men consuming the two bread products to define relationships between dietary intake, isoflavone metabolism and the biological outcomes. II. To describe the safety as well as incidence and severity of toxicity in men consuming the control soy bread or beta-glucosidase-enriched soy bread. III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy bread has a greater effect on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity. IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower circulating vascular endothelial growth factor concentrations. OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of 02/14/2011). ARM I: Patients consume 2 slices of soy bread daily for 8 weeks. ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks. After a 2 week washout period, patients crossover to the alternate treatment arm.

Conditions

• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Arm I Soy Bread	On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
DIETARY_SUPPLEMENT	Arm II Soy-Almond Bread	On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-06-01
• Completion: 2023-09-07
• First posted: 2012-09-11
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States