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


Phase 2
N/A
N/A
Open (Enrolling)
Male
Recurrent Prostate Cancer, Stage IV Prostate Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Yael Vodovotz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-08027

NCT ID:

NCT01682941

Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • soy, isoflavones, functional food, prostate cancer
  • Prostatic Neoplasms

Name

Location

The Ohio State University Medical CenterColumbus, Ohio  43210