Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888654
• Other study ID #: CDR0000641168
• Secondary ID: P30CA022453WSU-2
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2009
• Last updated: March 14, 2018
• Start date: August 2009
• Est. completion date: April 2014

Study information

• Verified date: November 2017
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• B-Dim
B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Procedure:
• Radical Prosatectomy

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Level of Diindolylmethane in Prostate Tissue After Treatment		Within the first 24 months after radical prostatectomy.
Secondary	Serum Levels of PSA, Testosterone, and Diindolylmethane	Serum levels of PSA, testosterone, and diindolylmethane (DIM)	Pre and post radical prostatectomy
Secondary	Levels of Androgen Receptor in Prostate Tissue	Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue.	Pre and post radical prostatectomy

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database