Clinical trial · Interventional
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
NCT00058266CI-TRIAL-00007490terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Data Monitoring Committee cited poor accrual.
Summary
Brief summary (as posted)
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
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 |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| genistein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
- interventionNames
- Dietary Supplement: genistein
- Procedure: conventional surgery
- type
- EXPERIMENTAL
- label
- Group B
- description
- Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
- interventionNames
- Dietary Supplement: genistein
- Procedure: conventional surgery
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of localized prostate cancer * Diagnosed within the past 6 months * T1 or T2 disease * Gleason score 5-8 * Prostate-specific antigen no greater than 20 ng/mL * Radical prostatectomy planned PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * More than 2 years Hematopoietic * Hemoglobin greater than 9.0 g/dL * Platelet count greater than 100,000/mm\^3 * Absolute neutrophil count greater than 1,000/mm\^3 Hepatic * SGPT and SGOT less than 3 times normal * Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis) Renal * Creatinine less than 2.0 mg/dL Cardiovascular * No venous thrombosis within the past year Other * Patients must use effective barrier contraception * No other medical condition that would preclude study therapy * No known soy intolerance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No concurrent hormonal therapy for prostate cancer Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No concurrent soy supplements * No concurrent foods high in genistein * No concurrent active therapy for neoplastic disorders
References
Publications (0)
Data not yet available
No reference posted for this study.