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

NCT00888654 | Completed Phase 2 Results

• 3 other identifiers: CDR0000641168P30CA022453WSU-2007-128
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer

Outcome Measures

Primary Outcomes (1)

• Mean Level of Diindolylmethane in Prostate Tissue After Treatment

  Within the first 24 months after radical prostatectomy.

Secondary Outcomes (2)

• Serum Levels of PSA, Testosterone, and Diindolylmethane

  Pre and post radical prostatectomy

• Levels of Androgen Receptor in Prostate Tissue

  Pre and post radical prostatectomy

Study Arms (1)

B-Dim, Radical Prosatectomy

EXPERIMENTAL

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

Drug: B-Dim; Procedure: Radical Prosatectomy

Interventions

B-Dim DRUG

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

Also known as: 3,3'-Diindolylmethane

B-Dim, Radical Prosatectomy

Radical Prosatectomy PROCEDURE

Also known as: therapeutic conventional surgery

B-Dim, Radical Prosatectomy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

3,3'-diindolylmethane

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

There were no significant limitations.

Results Point of Contact

• Title: Elisabeth Heath, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

heathe@karmanos.org

313-576-8715

Study Officials

• Elisabeth I. Heath, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 27, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 19, 2018
• Results First Posted: March 30, 2015

Record last verified: 2017-11

Locations

US (2)