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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: B-Dim; Procedure: Radical Prosatectomy

• Registration Number: NCT00888654
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

Study Timeline

• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-03-23
• Results First Submitted QC: 2015-03-23
• Results First Posted: 2015-03-30
• Status Verified: 2017-11
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B-Dim, Radical Prosatectomy	Radical Prosatectomy	B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy
B-Dim, Radical Prosatectomy	B-Dim	B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) Radical Prostatectomy

Primary Outcome Measures

Name	Time	Method
Mean Level of Diindolylmethane in Prostate Tissue After Treatment	Within the first 24 months after radical prostatectomy.

Secondary Outcome Measures

Name	Time	Method
Serum Levels of PSA, Testosterone, and Diindolylmethane	Pre and post radical prostatectomy	Serum levels of PSA, testosterone, and diindolylmethane (DIM)
Levels of Androgen Receptor in Prostate Tissue	Pre and post radical prostatectomy	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.

Trial Locations

Locations (2)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States