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

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ClinicalTrials.gov Identifier: NCT00888654
Recruitment Status : Completed
First Posted : April 27, 2009
Results First Posted : March 30, 2015
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 24, 2009
First Posted Date  ICMJE April 27, 2009
Results First Submitted Date  ICMJE March 23, 2015
Results First Posted Date  ICMJE March 30, 2015
Last Update Posted Date March 19, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Mean Level of Diindolylmethane in Prostate Tissue After Treatment [ Time Frame: Within the first 24 months after radical prostatectomy. ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
Mean level of diindolylmethane in prostate tissue after treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Serum Levels of PSA, Testosterone, and Diindolylmethane [ Time Frame: Pre and post radical prostatectomy ]
    Serum levels of PSA, testosterone, and diindolylmethane (DIM)
  • Levels of Androgen Receptor in Prostate Tissue [ Time Frame: Pre and post radical prostatectomy ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
  • Pre- and post-treatment serum levels of PSA, testosterone, and diindolylmethane
  • Pre- and post-treatment levels of androgen receptor, NF-kB, and PSA in prostate tissue
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
Official Title  ICMJE Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: B-Dim
    B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
    Other Name: 3,3'-Diindolylmethane
  • Procedure: Radical Prosatectomy
    Other Name: therapeutic conventional surgery
Study Arms  ICMJE Experimental: B-Dim, Radical Prosatectomy

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

Radical Prostatectomy

Interventions:
  • Drug: B-Dim
  • Procedure: Radical Prosatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2009)
30
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00888654
Other Study ID Numbers  ICMJE CDR0000641168
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP