Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
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.
Drug: oral microencapsulated diindolylmethane
Other: high performance liquid chromatography
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy|
- Mean level of diindolylmethane in prostate tissue after treatment [ Time Frame: Within the first 24 months after radical prostatectomy. ] [ Designated as safety issue: No ]
- Serum levels of PSA, testosterone,DIM level and diindolylmethane [ Time Frame: Pre and post radical prostatectomy ] [ Designated as safety issue: No ]
- Levels of androgen receptor, NF-kB, and PSA in prostate tissue [ Time Frame: Pre and post radical prostatectomy ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
- To measure the level of diindolylmethane in prostate tissue after treatment with oral microencapsulated diindolylmethane (B-DIM) in patients with stage I or II adenocarcinoma of the prostate undergoing radical prostatectomy.
- To measure serum biomarkers (e.g., total PSA, serum testosterone, and diindolylmethane levels) pre- and post-treatment with B-DIM.
- To measure tissue biomarkers (e.g., androgen receptor, NF-κB, and PSA) pre- and post-treatment with B-DIM.
OUTLINE: This is a multicenter study.
Patients receive oral microencapsulated diindolylmethane (B-DIM) twice daily for 14-72 days in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy 1 day after the last dose of B-DIM.
Patients undergo blood and tissue sample collection for correlative laboratory studies. Blood samples are analyzed for serum PSA, testosterone, and diindolylmethane levels by high performance liquid chromatography and tandem mass spectrometry (LC-MS/MS). Tissue samples are analyzed for diindolylmethane concentration by LC-MS/MS and for androgen receptor, activated NF-κB (p65 antibody), and PSA expression by IHC.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201-1379|
|Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 800-527-6266|
|Josephine Ford Cancer Center at Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Contact Person 313-916-1850|
|Principal Investigator:||Elisabeth I. Heath, MD||Barbara Ann Karmanos Cancer Institute|