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Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean level of diindolylmethane in prostate tissue after treatment

Outcome Time Frame:

Within the first 24 months after radical prostatectomy.

Safety Issue:

No

Principal Investigator

Elisabeth I. Heath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000641168

NCT ID:

NCT00888654

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202