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

NCT01682941 | Completed DMC

• 3 other identifiers: OSU-08027NCI-2010-02387R21CA125909
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Recurrent Prostate Cancer; Stage IV Prostate Cancer

Keywords

soy, isoflavones, functional food, prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (3)

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

  Day 0, 56, 70, and126

• Changes in hormonal patterns that favor anti-prostate cancer activity

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

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

  Day 0 and Day 126

Study Arms (2)

Soy Bread Intervention

ACTIVE COMPARATOR

Arm I Soy Bread

Dietary Supplement: Arm I Soy Bread

Soy -Almond Bread Intervention

EXPERIMENTAL

Arm II Soy-Almond Bread

Dietary Supplement: Arm II Soy-Almond Bread

Interventions

Arm I Soy Bread DIETARY_SUPPLEMENT

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.

Also known as: soy isoflavones, soy phytoestrogens

Soy Bread Intervention

Arm II Soy-Almond Bread DIETARY_SUPPLEMENT

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.

Also known as: soy isoflavones, soy phytoestrogens

Soy -Almond Bread Intervention

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Yael Vodovotz

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 11, 2012
• Study Start: October 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: September 7, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

US (1)