Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 3,3'-diindolylmethane

Criteria

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