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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450229 |
RATIONALE: Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body.
PURPOSE: 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 |
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Prostate Cancer |
Drug: oral microencapsulated diindolylmethane Procedure: biopsy Procedure: conventional surgery Procedure: gene expression analysis Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: neoadjuvant therapy Procedure: pharmacological study Procedure: polymerase chain reaction Procedure: polymorphism analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control |
Official Title: | Phase Ib Placebo-Controlled Trial of Diindolylmethane (BR-DIM) in the Study of Modulation of Intermediate Endpoint Markers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy |
Estimated Enrollment: | 45 |
Study Start Date: | October 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Patients in all arms undergo surgical resection of their tumor within 1 day after completion of DIM or placebo.
Patients undergo blood, tissue, and urine sample collection periodically during study for immunohistochemical (IHC)/molecular analyses and pharmacokinetic and pharmacogenomic correlative studies. Patient specimens are assessed for DIM levels in plasma and tissue (by liquid chromatography/mass spectrometry [LC/MS]) and for biologic response to DIM (by TUNEL assay). Intermediate biomarkers of DIM activity are also assessed, including urinary 2-hydroxyestrone:16-hydroxyestrone ratio (by LC/MS assay), plasma total prostate-specific antigen (PSA), plasma insulin-like growth factor (IGF)-1:IGF binding protein-3 ratio (by ELISA), and tissue androgen receptor, PSA, Ki-67, and caspase 3 (by immunohistochemistry). Cytochrome p450 induction and gene expression (CYP1A1, CYP1A2, CYP2B1, CYP3A) are also assessed in tissue and plasma by semiquantitative real-time polymerase chain reaction.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent p450 inducers or inhibitors, including any of the following:
No more than 1 serving of cruciferous vegetables per day for duration of study
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
South Coast Urological Medical Group | |
Laguna Hills, California, United States, 92653 | |
United States, New York | |
James P. Wilmot Cancer Center at University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, Texas | |
Urology San Antonio, PA - Fredericksburg | |
San Antonio, Texas, United States, 78229 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Principal Investigator: | Jason R. Gee, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000534115, WCCC-CO05186, WCCC-H2006-0255, WCCC-06-1270-02 |
Study First Received: | March 20, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00450229 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site |