Clinical trial · Interventional
Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
NCT00888654CI-TRIAL-00032119completedPhase 2Results 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)
RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow the growth of tumor cells. PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients with stage I or stage II prostate cancer undergoing 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 |
|---|---|---|---|
| B-Dim | Drug | — | UNRESOLVED |
| Radical Prosatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B-Dim, Radical Prosatectomy
- description
- B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy
- interventionNames
- Drug: B-Dim
- Procedure: Radical Prosatectomy
Primary outcomes (1)
- measure
- Mean Level of Diindolylmethane in Prostate Tissue After Treatment
- timeFrame
- Within the first 24 months after radical prostatectomy.
Secondary outcomes (2)
- measure
- Serum Levels of PSA, Testosterone, and Diindolylmethane
- timeFrame
- Pre and post radical prostatectomy
- description
- Serum levels of PSA, testosterone, and diindolylmethane (DIM)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Stage I or II (T1-T2 a, b, or c) disease * Disease confined to the prostate by clinical judgment of the surgeon * Deemed an appropriate candidate for surgery by clinical judgment of the surgeon PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and/or ALT ≤ 2.5 times ULN if alkaline phosphatase normal OR alkaline phosphatase ≤ 4 times ULN if AST and/or ALT normal * Serum creatinine ≤ 2.0 mg/dL * No history of allergic reactions attributed to compounds of similar chemical or biological composition to oral microencapsulated diindolylmethane * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive hart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * No prior chemotherapy, hormonal therapy, brachytherapy, cryotherapy, external beam radiotherapy, or other therapy for prostate cancer * No concurrent micronutrient supplements or dietary soy products * No concurrent systemic therapy for any other cancer * No concurrent p450 inducers or inhibitors (e.g., carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, or rifampin) * No concurrent finasteride or dutasteride * No other concurrent investigational or commercial agents or therapies for the malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.