Clinical trial · Interventional
Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer
Phase Ib Placebo-Controlled Trial of Diindolylmethane (BR-DIM) in the Study of the Modulation of Intermediate Endpoint Markers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
NCT00450229CI-TRIAL-00020074completedPhase 1ClinicalTrials.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)
Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body. This randomized phase I trial is studying the side effects and best dose of diindolylmethane compared with a placebo in treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.
Conditions
Conditions (4)
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 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diindolylmethane | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
- interventionNames
- Drug: diindolylmethane
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.
- interventionNames
- Drug: diindolylmethane
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- Other: pharmacological study
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1 or T2 a, b, or c (stage I-II disease) * Disease is confined within the prostate gland * Candidate for radical prostatectomy * ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100% * WBC normal * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL * AST =\< 1.5 times upper limit of normal * Creatinine =\< 2.0 mg/dL * Fertile patients must use effective contraception * No history of allergic reactions attributed to diindolylmethane (DIM\^), any of the inactive ingredients contained in BioResponse-DIM\^NG or placebo, or to compounds of similar chemical or biologic composition * No concurrent uncontrolled illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, No psychiatric illness or social situation that would preclude study compliance * No prior chemotherapy, hormonal therapy, brachytherapy, or external radiotherapy for prostate cancer * No concurrent nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, ibuprofen, naproxen sodium, or cyclooxygenase-2 inhibitors * No concurrent systemic therapy for any other cancer * No other concurrent investigational agents * No concurrent p450 inducers or inhibitors, including any of the following: Carbamazepine, Clarithromycin, Fluconazole, Fosphenytoin, Itraconazole, Ketoconazole, Phenobarbital, Phenytoin, Rifabutin, Rifampin * No concurrent finasteride or dutasteride * No more than 1 serving of cruciferous vegetables per day for duration of study * Cruciferous vegetables include the following: broccoli, cauliflower, brussels sprouts, cabbage, arugula, watercress, bok-choy, turnip greens, mustard greens, collard greens, rutabaga, Napa or Chinese cabbage, radishes, turnips, kohlrabi, and kale * Bilirubin normal * At least 21 days since prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.