Clinical trial NCT00888654: Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
Official title: Phase II Trial of B-DIM (DIM: 3,3 Diindolylmethane) on Intermediate Endpoint Biomarkers in Patients With Prostate Cancer Who Are Undergoing Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-27
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean Level of Diindolylmethane in Prostate Tissue After Treatment
timeFrame: Within the first 24 months after radical prostatectomy.
Secondary outcomes:
measure: Serum Levels of PSA, Testosterone, and Diindolylmethane
timeFrame: Pre and post radical prostatectomy
measure: Levels of Androgen Receptor in Prostate Tissue
timeFrame: Pre and post radical prostatectomy
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Elisabeth I. Heath, MD
role: PRINCIPAL_INVESTIGATOR
References: