Clinical trial · Interventional
Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
Effects of Dietary Soy on Biomarkers of Prostate Cancer: A Prospective Phase II Study
NCT00031746CI-TRIAL-00023134completedPhase 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: Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (PSA) levels. PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels.
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 |
|---|---|---|---|
| casein proteins | Dietary Supplement | — | UNRESOLVED |
| soy protein isolate | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- soy protein + isoflavones
- interventionNames
- Dietary Supplement: soy protein isolate
- type
- ACTIVE_COMPARATOR
- label
- casein proteins
- interventionNames
- Dietary Supplement: casein proteins
Primary outcomes (1)
- measure
- Reduction of prostatic cellular proliferation rates by 50% as measured by Ki-67
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed absence of prostate cancer * Atypical adenomatous hyperplasia or prostatic intraepithelial neoplasia (high-grade or low-grade) allowed * Abnormal baseline transrectal ultrasound and digital rectal exam allowed * Biopsy may be before or after study entry, but must be within the past 90 days * PSA 5-10 ng/mL PATIENT CHARACTERISTICS: Age: * 50 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No known allergy to soy protein or milk protein * No invasive cancer within the past 5 years except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior hormonal therapy * No prior finasteride * No concurrent hormonal therapy * No concurrent finasteride Radiotherapy: * Not specified Surgery: * At least 6 months since prior transurethral resection of the prostate * No prior orchiectomy * No concurrent orchiectomy Other: * No other concurrent soy products
References
Publications (0)
Data not yet available
No reference posted for this study.