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
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Prostate Cancer focused on measuring soy, isoflavones, functional food, prostate cancer
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.
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
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
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
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
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
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)
Time Frame
Day 0 and Day 126
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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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