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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yael Vodovotz, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01682941
First received: September 6, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Dietary Supplement: Arm I Soy Bread
Dietary Supplement: Arm II Soy-Almond Bread
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites [ Time Frame: 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0, 56, 70, and126 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 0, 28, 56, 70, 98, and 126 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 and Day 126 ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Soy Bread Intervention
Arm I Soy Bread
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.
Other Names:
  • soy isoflavones
  • soy phytoestrogens
Experimental: Soy -Almond Bread Intervention
Arm II Soy-Almond Bread
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.
Other Names:
  • soy isoflavones
  • soy phytoestrogens

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682941

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Yael Vodovotz Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Yael Vodovotz, Associate Professor, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01682941     History of Changes
Other Study ID Numbers: OSU-08027, NCI-2010-02387, R21CA125909
Study First Received: September 6, 2012
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
soy, isoflavones, functional food, prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014