Status:
COMPLETED
Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 eff...
Detailed Description
PRIMARY OBJECTIVES: I. Compare neoadjuvant prostatic diindolylmethane (DIM\^) concentrations in patients with stage I or II adenocarcinoma of the prostate treated with DIM vs placebo prior to radical...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00450229
Start Date
February 1 2007
End Date
February 1 2010
Last Update
December 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792