Clinical trial · Interventional
Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen
Bioavailability of Isoflavones Delivered by Soy Almond Bread in Men With Recurring Prostate Cancer and Rising Prostate Specific Antigen
NCT01682941CI-TRIAL-00071579completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm II Soy-Almond Bread | Dietary Supplement | — | UNRESOLVED |
| Arm I Soy Bread | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Soy Bread Intervention
- description
- Arm I Soy Bread
- interventionNames
- Dietary Supplement: Arm I Soy Bread
- type
- EXPERIMENTAL
- label
- Soy -Almond Bread Intervention
- description
- Arm II Soy-Almond Bread
- interventionNames
- Dietary Supplement: Arm II Soy-Almond Bread
Primary outcomes (1)
- measure
- Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites
- timeFrame
- 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.