Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean level of diindolylmethane in prostate tissue after treatment
Within the first 24 months after radical prostatectomy.
Elisabeth I. Heath, MD
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|