Phase 3
Completed N=86
Role of Soy Supplementation in Prostate Cancer Development
Source: ClinicalTrials.gov NCT00255125 ↗Enrolled (actual)
86
Serious AEs
9.3%
Results posted
Jun 2015
Primary outcomePrimary: Effect of Soy Isoflavones on Serum Testosterone Levels. — 376; 405 ng/ml
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Soy Isoflavones on Serum Testosterone Levels. |
376; 405 | — |
| SECONDARY Effect of Soy Isoflavones on Estrogen Receptor Status |
130; 131 | — |
| SECONDARY Molecular Effects of Soy Supplementation Compared to Placebo. |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00255125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.