Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy

Study Overview
=================
Brief 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.

Detailed Description
-----------------
OBJECTIVES: Primary 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. Secondary 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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: B-Dim
* Procedure: Radical Prosatectomy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-Dim, Radical Prosatectomy<br>B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy | Drug: B-Dim<br>* B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)<br>* Other names: 3,3'-Diindolylmethane;Procedure: Radical Prosatectomy<br> <br> * Other names: therapeutic conventional surgery;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Level of Diindolylmethane in Prostate Tissue After Treatment |  | Within the first 24 months after radical prostatectomy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Levels of PSA, Testosterone, and Diindolylmethane | Serum levels of PSA, testosterone, and diindolylmethane (DIM) | Pre and post radical prostatectomy | 
| Levels of Androgen Receptor in Prostate Tissue | Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue. | Pre and post radical prostatectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer