Clinical trial · Interventional
Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer
Phase II Randomized Study of Soy Isoflavones in Patients With Localized Prostate Cancer Treated With Radiation Therapy
- 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 slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells and prevent further development of prostate cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving isoflavones together with radiation therapy may be an effective treatment for prostate cancer. PURPOSE: This randomized phase II trial is studying the side effects and how well giving isoflavones together with radiation therapy works in treating patients with localized prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| soy protein isolate | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Oxidative DNA damage at 3 and 6 months
Secondary outcomes (4)
- measure
- Quality of life as measured by questionnaire at 3 and 6 months
- measure
- Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months
- measure
- Response as measured by prostate-specific antigen and clinical assessment at 3 and 6 months
- measure
- Isoflavone serum level at 3 and 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate that is localized to the prostate gland * Must be scheduled to receive curative radiotherapy for prostate cancer * Not eligible for a higher priority study at the Karmanos Cancer Institute PATIENT CHARACTERISTICS: Performance status * 0-3 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No organ function restrictions PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Endocrine therapy * No prior hormonal therapy Radiotherapy * See Disease Characteristics Other * No other concurrent micronutrient supplements, herbs, or vitamins except 1 daily multivitamin
References
Publications (0)
Data not yet available