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

Primary Purpose

Recurrent Prostate Cancer, Stage IV Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Arm I Soy Bread

Arm II Soy-Almond Bread

About this trial

This is an interventional treatment trial for Recurrent Prostate Cancer focused on measuring soy, isoflavones, functional food, prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Have histologically confirmed prostate cancer.
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.
Not be receiving ongoing chemotherapy, radiation therapy or biological therapy for internal malignancy including prostate cancer.
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.
Not be currently using Finasteride, androgens, or other PSA modifying hormonal agents. Utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. The use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products).
Have kidney and liver enzymes within normal limits. Men with kidney and liver enzymes that are slightly elevated (< 1.5 times the upper normal limit), but have been stable for several months particularly those that are related to a known disorder (such as Gilberts syndrome, past history of alcohol, hepatitis, or a history of non-alcoholic steatohepatitis) will be permitted to participate after clinical evaluation by the study physician."
Have no history of malabsorptive disorders or other metabolic disorders requiring special diet recommendations. Diabetics will be permitted to participate.
Voluntarily agree to participate and a sign an informed consent document.
Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study.

Exclusion Criteria:

Have an active malignancy other than prostate cancer that requires therapy.
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).
Antibiotic use in the last 6 months.

Sites / Locations

The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Soy Bread Intervention

Soy -Almond Bread Intervention

Arm Description

Arm I Soy Bread

Arm II Soy-Almond Bread

Outcomes

Primary Outcome Measures

Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites

Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes

Secondary Outcome Measures

Change in hormonal patterns after soy bread and soy-almond bread interventions

Comparison of hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein-3, lower androgens), prostate specific antigen velocity, and circulating vascular endothelial growth factor concentrations

Changes in hormonal patterns that favor anti-prostate cancer activity

Comparison of isoflavone metabolites on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.

Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread

Safety (NIH criteria) and toxicity will be measured at day 0 (start of first intervention), day 56 (end of first intervention), day 70 (start of second intervention), and day 126 (end of second intervention)

Full Information

NCT ID

NCT01682941

First Posted

September 6, 2012

Last Updated

March 23, 2023

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01682941

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2009 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Prostate Cancer, Stage IV Prostate Cancer

Keywords

soy, isoflavones, functional food, prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Soy Bread Intervention

Arm Type

Active Comparator

Arm Description

Arm I Soy Bread

Arm Title

Soy -Almond Bread Intervention

Arm Type

Experimental

Arm Description

Arm II Soy-Almond Bread

Intervention Type

Dietary Supplement

Intervention Name(s)

Arm I Soy Bread

Other Intervention Name(s)

soy isoflavones, soy phytoestrogens

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Arm II Soy-Almond Bread

Other Intervention Name(s)

soy isoflavones, soy phytoestrogens

Intervention Description

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.

Primary Outcome Measure Information:

Title

Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites

Description

Time Frame

0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose

Secondary Outcome Measure Information:

Title

Change in hormonal patterns after soy bread and soy-almond bread interventions

Description

Time Frame

Day 0, 56, 70, and126

Title

Changes in hormonal patterns that favor anti-prostate cancer activity

Description

Comparison of isoflavone metabolites on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.

Time Frame

Days 0, 28, 56, 70, 98, and 126

Title

Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread

Description

Time Frame

Day 0 and Day 126

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have histologically confirmed prostate cancer. 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. Not be receiving ongoing chemotherapy, radiation therapy or biological therapy for internal malignancy including prostate cancer. 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. Not be currently using Finasteride, androgens, or other PSA modifying hormonal agents. Utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. The use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products). Have kidney and liver enzymes within normal limits. Men with kidney and liver enzymes that are slightly elevated (< 1.5 times the upper normal limit), but have been stable for several months particularly those that are related to a known disorder (such as Gilberts syndrome, past history of alcohol, hepatitis, or a history of non-alcoholic steatohepatitis) will be permitted to participate after clinical evaluation by the study physician." Have no history of malabsorptive disorders or other metabolic disorders requiring special diet recommendations. Diabetics will be permitted to participate. Voluntarily agree to participate and a sign an informed consent document. Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study. Exclusion Criteria: Have an active malignancy other than prostate cancer that requires therapy. 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). Antibiotic use in the last 6 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yael Vodovotz

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

Jamesline

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

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