Clinical trial · Interventional
Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
NCT00345813CI-TRIAL-00034281completedPhase 2ClinicalTrials.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: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery. PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| soy isoflavones | Dietary Supplement | — | UNRESOLVED |
| soy protein isolate | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
- interventionNames
- Dietary Supplement: soy isoflavones
- Dietary Supplement: soy protein isolate
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Correlation of pretreatment ER-β expression with response to soy supplementation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinically localized disease * Scheduled for radical prostatectomy * No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * No evidence of active nephrolithiasis * No history of hypercalcemic syndrome PRIOR CONCURRENT THERAPY: * No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs * No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil
References
Publications (0)
Data not yet available
No reference posted for this study.