Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450229
First received: March 20, 2007
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body. This randomized phase I trial is studying the side effects and best dose of diindolylmethane compared with a placebo in treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Drug: diindolylmethane
Drug: placebo
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase Ib Placebo-Controlled Trial of Diindolylmethane (BR-DIM) in the Study of the Modulation of Intermediate Endpoint Markers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tissue levels of DIM [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The distribution of levels of DIM will be summarized by treatment arm with descriptive statistics. For the primary comparison between the placebo group and the DIM groups combined, tissue levels of DIM will be compared using Student t-test. In the case of violation of normality assumptions, an appropriate transformation of the data such as logarithm will be considered or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison. A dose-response relation will be explored based on the analysis of covariance (ANCOVA).


Secondary Outcome Measures:
  • Urinary 2-hydroxyestrone/16-hydroxyestrone ratio [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.

  • Total PSA [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.

  • Serum testosterone [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.

  • IGF1:IGFBP-3 ratio [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.

  • Tissue measures of messenger RNA of CYPs (CYP1A2, CYP1A1, CYP2B1, CYP3A) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.

  • DIM blood steady-state concentrations [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.

  • Measures of androgen receptor, PSA, Ki-67, caspase 3, and TUNEL [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be summarized by treatment arm with descriptive statistics.


Enrollment: 45
Study Start Date: February 2007
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
Drug: diindolylmethane
Given PO
Other Name: DIM
Procedure: therapeutic conventional surgery
Undergo surgical resection
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Experimental: Arm II
Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.
Drug: diindolylmethane
Given PO
Other Name: DIM
Procedure: therapeutic conventional surgery
Undergo surgical resection
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Placebo Comparator: Arm III
Patients receive oral placebo twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.
Drug: placebo
Given PO
Other Name: PLCB
Procedure: therapeutic conventional surgery
Undergo surgical resection
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1 or T2 a, b, or c (stage I-II disease)
  • Disease is confined within the prostate gland
  • Candidate for radical prostatectomy
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
  • WBC normal
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 10 g/dL
  • AST =< 1.5 times upper limit of normal
  • Creatinine =< 2.0 mg/dL
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to diindolylmethane (DIM^), any of the inactive ingredients contained in BioResponse-DIM^NG or placebo, or to compounds of similar chemical or biologic composition
  • No concurrent uncontrolled illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, No psychiatric illness or social situation that would preclude study compliance
  • No prior chemotherapy, hormonal therapy, brachytherapy, or external radiotherapy for prostate cancer
  • No concurrent nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, ibuprofen, naproxen sodium, or cyclooxygenase-2 inhibitors
  • No concurrent systemic therapy for any other cancer
  • No other concurrent investigational agents
  • No concurrent p450 inducers or inhibitors, including any of the following: Carbamazepine, Clarithromycin, Fluconazole, Fosphenytoin, Itraconazole, Ketoconazole, Phenobarbital, Phenytoin, Rifabutin, Rifampin
  • No concurrent finasteride or dutasteride
  • No more than 1 serving of cruciferous vegetables per day for duration of study
  • Cruciferous vegetables include the following: broccoli, cauliflower, brussels sprouts, cabbage, arugula, watercress, bok-choy, turnip greens, mustard greens, collard greens, rutabaga, Napa or Chinese cabbage, radishes, turnips, kohlrabi, and kale
  • Bilirubin normal
  • At least 21 days since prior surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450229

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Investigators
Principal Investigator: Jason Gee University of Wisconsin Hospital and Clinics
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450229     History of Changes
Other Study ID Numbers: NCI-2009-00905, CO05816, CDR0000656281, H2006-0255, N01CN35153
Study First Received: March 20, 2007
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014