View Clinical Trial (Medical Research Study)
Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
| City: |
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Detroit |
| State: |
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Michigan |
| Zip Code: |
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48202 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00888654 |
| Primary Contact: |
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Principal Investigator
Elisabeth I. Heath, MD
Barbara Ann Karmanos Cancer Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Detroit, Michigan 48202
United States
Contact Person
Phone: 313-916-1850
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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