Clinical trial · Interventional
Role of Soy Supplementation in Prostate Cancer Development
Role of Soy Isoflavones in Prostate Cancer Prevention
NCT00255125CI-TRIAL-00039114completedPhase 3Results postedClinicalTrials.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)
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.
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 Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Soy Supplement | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Arm Soy Supplement
- description
- Soy Supplement
- interventionNames
- Drug: Soy Supplement
Primary outcomes (1)
- measure
- Effect of Soy Isoflavones on Serum Testosterone Levels.
- timeFrame
- Two weeks
- description
- Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer. * Surgical candidate for prostatectomy. * During study period, must agree not to take new supplements. * No concurrent chemotherapy, radiation or hormonal therapy. * No history of prior allergy to soy based products. * Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment. * Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy. * Must give written and informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: During study period, must agree not to take new supplements. * No concurrent chemotherapy, radiation or hormonal therapy. * No history of prior allergy to soy based products. * Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment. * Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
References
Publications (1)
- RESULTHamilton-Reeves JM, Banerjee S, Banerjee SK, Holzbeierlein JM, Thrasher JB, Kambhampati S, Keighley J, Van Veldhuizen P. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial. PLoS One. 2013 Jul 12;8(7):e68331. doi: 10.1371/journal.pone.0068331. Print 2013. PMID 23874588