Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

3,3'-diindolylmethane

Protective Agents

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

Radical Prostatectomy

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

B-Dim

Radical Prosatectomy

Elisabeth I. Heath, MD

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.

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.

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

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

Serum levels of PSA, testosterone, and diindolylmethane (DIM)

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.

National Cancer Institute (NCI)

Barbara Ann Karmanos Cancer Institute

Principal Investigator

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

Radical Prostatectomy

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

Radical Prosatectomy

B-Dim, Radical Prosatectomy

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Elisabeth Heath, M.D.

Patients that were eligible, evaluable, and compliant

Mean Level of Diindolylmethane in Prostate Tissue After Treatment

Pre-treatment PSA

Post-treatment PSA

Pre-treatment Testosterone

Post-treatment Testosterone

Pre-treatment DIM

Post-treatment DIM

All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.

Spots Global Cancer Trial Database for radical prosatectomy