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

NCT01682941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-11-22

No results posted yet for this study

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

Conditions

  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Yael Vodovotz · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-06-30
Completion
2023-09-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01682941 on ClinicalTrials.gov