Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01682941
Other study ID # OSU-08027
Secondary ID NCI-2010-02387R2
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date September 7, 2023

Study information

Verified date November 2023
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 7, 2023
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States The Ohio State University Medical Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Day 0, 56, 70, and126
Secondary 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. Days 0, 28, 56, 70, 98, and 126
Secondary 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) Day 0 and Day 126
See also
  Status Clinical Trial Phase
Completed NCT02217709 - Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer Phase 2
Recruiting NCT03718260 - PSMA-PET Registry for Recurrent Prostate Cancer N/A
Active, not recruiting NCT01685125 - Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT01054079 - Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer Phase 2
Terminated NCT00512668 - Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer Phase 1
Completed NCT00103194 - Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer Phase 2
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Recruiting NCT05304858 - Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Completed NCT02250014 - The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer Phase 1
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Not yet recruiting NCT06070272 - Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT01260688 - Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel Phase 2
Completed NCT01220817 - Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study Phase 2
Completed NCT00775866 - MRI-Guided Biopsy of Recurrent Prostate Cancer After Radiotherapy N/A
Completed NCT00074022 - GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT05044754 - SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy
Active, not recruiting NCT01923506 - Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery Phase 1
Completed NCT01808222 - FACBC for Recurrent Prostate Cancer Phase 2

External Links