Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: B-Dim; Radical Prosatectomy
Intervention description: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Intervention MeSH terms: 3,3'-diindolylmethane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer

Summary:

      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.
    

Eligibility criteria:

        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