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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
B-Dim
Radical Prosatectomy
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

B-Dim, Radical Prosatectomy

Arm Description

B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy

Outcomes

Primary Outcome Measures

Mean Level of Diindolylmethane in Prostate Tissue After Treatment

Secondary Outcome Measures

Serum Levels of PSA, Testosterone, and Diindolylmethane
Serum levels of PSA, testosterone, and diindolylmethane (DIM)
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.

Full Information

First Posted
April 24, 2009
Last Updated
March 14, 2018
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00888654
Brief Title
Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B-Dim, Radical Prosatectomy
Arm Type
Experimental
Arm Description
B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy
Intervention Type
Drug
Intervention Name(s)
B-Dim
Other Intervention Name(s)
3,3'-Diindolylmethane
Intervention Description
B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
Intervention Type
Procedure
Intervention Name(s)
Radical Prosatectomy
Other Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Mean Level of Diindolylmethane in Prostate Tissue After Treatment
Time Frame
Within the first 24 months after radical prostatectomy.
Secondary Outcome Measure Information:
Title
Serum Levels of PSA, Testosterone, and Diindolylmethane
Description
Serum levels of PSA, testosterone, and diindolylmethane (DIM)
Time Frame
Pre and post radical prostatectomy
Title
Levels of Androgen Receptor in Prostate Tissue
Description
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.
Time Frame
Pre and post radical prostatectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth I. Heath, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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