Completed

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

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What is being tested

Arm I Soy Bread

+ Arm II Soy-Almond Bread

Dietary Supplement
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2009
See protocol details

Summary

Principal SponsorOhio State University Comprehensive Cancer Center
Last updated: November 22, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01682941
Principal SponsorOhio State University Comprehensive Cancer Center
Last updated: November 22, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

10 inclusion criteria required to participate
Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
At time of entry, the clinical team expects that no additional interventions for prostate cancer therapy (hormonal, chemotherapy, radiotherapy, etc.) will be necessary over the next 5 months
Have completed primary therapy (radical prostatectomy, external beam radiation, brachytherapy) for prostate cancer. "Watchful waiting" patients will also be eligible
Have either two consecutive rises in prostate specific antigen (PSA) or a series of at least four PSA's over two years where the PSA doubling time is at least 3 months following a nadir response to localized therapy. The minimum PSA for this study is 0.2 ng/dL
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5 exclusion criteria prevent from participating
Antibiotic use in the last 6 months
Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes, osteoporosis and men who have been stable ( > 6 months of thyroid stimulating hormone within normal limits) on thyroid replacement therapy
Have a known allergy to tree nuts, soy or wheat protein
Have a recent history of iron deficient anemia (possible accentuation by soy)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Arm I Soy Bread

Group II

Experimental
Arm II Soy-Almond Bread

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Ohio State University Medical Center

Columbus, United StatesOpen The Ohio State University Medical Center in Google Maps
CompletedOne Study Center