Prostate AdenocarcinomaPhase 2NCT03654638

Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer

A Phase 2 study testing Dietary Intervention and Questionnaire Administration in people with Prostate Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Adenocarcinoma
What is being tested?: Dietary Intervention and Questionnaire Administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2018to 9 Mar 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have biopsy proven adenocarcinoma of the prostate (no small cell, sarcomatoid, or other rare subtypes)
Be planning a course of at least 5 months of androgen deprivation therapy. Patients who have had androgen deprivation therapy in the past as part of salvage therapy or primary therapy, but are initiating a new course will be eligible.
Have a testosterone concentration within normal limits.
No neoadjuvant hormonal or chemotherapy (other clinical trials) for their prostate cancer
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Have blood, urea, nitrogen (BUN)/creatinine (Cr), liver enzymes, complete blood count (CBC), and prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) within normal limits

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Voluntarily agree to participate and a sign an informed consent document
Agree to have prostate biopsy blocks provided to the study for evaluation
Willing to discontinue all current vitamin/mineral supplements
Not currently be taking complementary or alternative products (i.e. PC-SPES, Saw Palmetto) that target the prostate or may impact the hormonal environment
Agree to consume a standardized vitamin and mineral supplement (provided by the study) and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study

Who cannot join

Have an active malignancy other than prostate cancer that requires therapy
No diagnosed hematologic malignancy
Not currently taking steroid medications (i.e., chronic lymphocytic leukemia [CLL])
No chronic infection (i.e., human immunodeficiency virus-positive [HIV+])
No history of organ transplant requiring immunosuppressive medications
History of nephrolithiasis (renal stones)
Renal insufficiency with creatinine > 1.8, including anyone on dialysis regardless of nadir creatinine
Have certain medical conditions. Have no history of malabsorptive disorders or other metabolic disorders requiring special diet recommendations (for example, Crohn?s disease or gluten enteropathy)

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer

This phase II trial studies the effects of a soy bread versus a wheat bread in improving immune function in participants who are beginning a course of androgen deprivation therapy for prostate cancer. Components found in soy foods may influence the immune system in a way that may be beneficial for prostate cancer prevention and survivorship.

Read the detailed description

PRIMARY OBJECTIVES:

To precisely define the impact of soy on myeloid derived suppressor cells (MDSC) in a human model clinical trial.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (SOY BREAD): Participants consume 2 slices of soy bread daily for approximately 20 weeks in the absence of unacceptable toxicity. Concurrent with the intervention, participants will be staring androgen deprivation therapy at the direction of their medical oncologist.

ARM II (WHEAT BREAD): Participants consume 2 slices of wheat bread daily for approximately 20 weeks in the absence of unacceptable toxicity. Concurrent with the intervention, participants will be staring androgen deprivation therapy at the direction of their medical oncologist.

Conditions: Prostate Adenocarcinoma
Being tested: Dietary Intervention, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary InterventionCombination product
Also called Dietary Modification, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy
Dietary InterventionCombination product
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT03654638
Study group	Role	What they receive
Arm I Soy Bread Intervention	Experimental	Men who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of soy bread daily for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits. Receives: Combination Product: Dietary Intervention; Other: Questionnaire Administration
Arm II Wheat Bread Intervention	Active comparator	Men who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of wheat bread for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits. Receives: Combination Product: Dietary Intervention; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in peripheral blood myeloid derived suppressor cells (MDSC)
A two-sample t-test will be used to compare the differences (log-transformed if necessary to improve normality).
Measured: Week 0 to week 20
Treatment effect on peripheral blood MDSC
Mixed-effects regression models will be used to estimate the treatment effect on peripheral blood MDSC after adjusting for covariates such as age, compliance, and weight. A condition by time (pre versus [vs.] post) interaction will be included to test for a treatment effect. A random effect will be included for each subject to account for the dependency between the pre-post measurements. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 5 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used. Tissue MDSC will be compared using linear regression.
Measured: Up to week 20
Treatment effects in plasma cytokines
Mixed-effects regression models will be used to estimate the treatment effect. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 5 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used.
Measured: Up to week 20
Treatment effects in T-cell proliferation
Mixed-effects regression models will be used to estimate the treatment effect. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 20 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used.
Measured: Up to week 20
Treatment effects in prostate specific antigen (PSA)
Mixed-effects regression models will be used to estimate the treatment effect.
Measured: Up to week 20

Secondary outcomes (1)

PSA response
Mixed-effects models will be used to explore treatment effects in PSA outcomes
Measured: Up to week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20189 Mar 2022

First posted31 Aug 2018
Study start15 Aug 2018
Primary completion9 Mar 2022
Study completion9 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03654638
Sponsor's protocol ID: OSU-12042
Other IDs: NCI-2018-00808, R01CA169363
Status last verified: Apr 2025
First submitted: 29 Aug 2018
Last updated: 4 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
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All Prostate Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer
ClinicalTrials.gov ID: NCT03654638
Acronym / sponsor ID: OSU-12042
Conditions: Prostate Adenocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 15 Aug 2018 (actual)
Primary completion: 9 Mar 2022 (actual)
Study completion: 9 Mar 2022 (actual)
First posted: 31 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To precisely define the impact of soy on myeloid derived suppressor cells (MDSC) in a human model clinical trial.

OUTLINE: Participants are randomized to 1 of 2 arms.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I Soy Bread Intervention	Experimental	Combination Product: Dietary Intervention, Other: Questionnaire AdministrationMen who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of soy bread daily for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits.
Arm II Wheat Bread Intervention	Active comparator	Combination Product: Dietary Intervention, Other: Questionnaire AdministrationMen who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of wheat bread for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Have biopsy proven adenocarcinoma of the prostate (no small cell, sarcomatoid, or other rare subtypes)
Be planning a course of at least 5 months of androgen deprivation therapy. Patients who have had androgen deprivation therapy in the past as part of salvage therapy or primary therapy, but are initiating a new course will be eligible.
Have a testosterone concentration within normal limits.
No neoadjuvant hormonal or chemotherapy (other clinical trials) for their prostate cancer
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Key exclusion criteria (8 listed)

Have an active malignancy other than prostate cancer that requires therapy
No diagnosed hematologic malignancy
Not currently taking steroid medications (i.e., chronic lymphocytic leukemia [CLL])
No chronic infection (i.e., human immunodeficiency virus-positive [HIV+])
No history of organ transplant requiring immunosuppressive medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dietary InterventionAlso: Dietary Modification, Nutrition Intervention, Nutrition Interventions, Nutritional InterventionsThe dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy	Combination product	Arm I Soy Bread Intervention
Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsThe dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy	Combination product	Arm II Wheat Bread Intervention
Questionnaire AdministrationAncillary studies	Other	Arm I Soy Bread Intervention, Arm II Wheat Bread Intervention

Primary outcome

Change in peripheral blood myeloid derived suppressor cells (MDSC)
Time frame: Week 0 to week 20
A two-sample t-test will be used to compare the differences (log-transformed if necessary to improve normality).
Treatment effect on peripheral blood MDSC
Time frame: Up to week 20
Mixed-effects regression models will be used to estimate the treatment effect on peripheral blood MDSC after adjusting for covariates such as age, compliance, and weight. A condition by time (pre versus [vs.] post) interaction will be included to test for a treatment effect. A random effect will be included for each subject to account for the dependency between the pre-post measurements. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 5 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used. Tissue MDSC will be compared using linear regression.
Treatment effects in plasma cytokines
Time frame: Up to week 20
Mixed-effects regression models will be used to estimate the treatment effect. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 5 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used.
Treatment effects in T-cell proliferation
Time frame: Up to week 20
Mixed-effects regression models will be used to estimate the treatment effect. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 20 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used.
Treatment effects in prostate specific antigen (PSA)
Time frame: Up to week 20
Mixed-effects regression models will be used to estimate the treatment effect.

1 secondary outcome

PSA response
Time frame: Up to week 20

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
The JameslineLink provided by the sponsor.

Related trials for Prostate Adenocarcinoma

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
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Not yet recruitingPhase 2
Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Clinton, MD principal investigator

Ohio State University Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peripheral blood myeloid derived suppressor cells (MDSC) (time frame: Week 0 to week 20). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.