Clinical trial · Interventional
Genistein in Treating Patients With Prostate Cancer
Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
NCT01126879CI-TRIAL-00040484terminatedPhase 2Results postedClinicalTrials.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): Closed due to low accrual
Summary
Brief summary (as posted)
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| genistein | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
- interventionNames
- Dietary Supplement: genistein
- Procedure: therapeutic conventional surgery
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
- interventionNames
- Other: placebo
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA \>= 10, Gleason score \>= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review * ECOG performance status 0-1 * Hemoglobin \> 9.0gm/dl * Platelets \>= 100 K/uL * ANC \> 1000/uL * AST (SGOT)/ALT (SGPT) \< 3X upper limit of normal * Creatinine \< 2.0 mg/dl * Total bilirubin \< 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis) * Participants must agree not to take soy supplements * Ability to understand and the willingness to sign a written informed consent document * Willingness to take study agent for at least 2 weeks prior to radical prostatectomy Exclusion * History of venous thrombosis within past year * Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer) * Participants may not be receiving any other investigational agents * Known soy intolerance * Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
References
Publications (0)
Data not yet available
No reference posted for this study.