Diindolylmethane in Treating Patients Undergoing Surgery for Stage I or Stage II Prostate Cancer

NCT00450229 | Completed Phase 1

• 5 other identifiers: NCI-2009-00905CO05816CDR0000656281H2006-0255N01CN35153
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Giving diindolylmethane, a substance found in cruciferous vegetables, may help doctors learn more about how diindolylmethane is used by the body. This randomized phase I trial is studying the side effects and best dose of diindolylmethane compared with a placebo in treating patients undergoing radical prostatectomy for stage I or stage II prostate cancer.

Conditions

Adenocarcinoma of the Prostate; Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Tissue levels of DIM

  The distribution of levels of DIM will be summarized by treatment arm with descriptive statistics. For the primary comparison between the placebo group and the DIM groups combined, tissue levels of DIM will be compared using Student t-test. In the case of violation of normality assumptions, an appropriate transformation of the data such as logarithm will be considered or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison. A dose-response relation will be explored based on the analysis of covariance (ANCOVA).

  Up to 5 years

Secondary Outcomes (7)

• Urinary 2-hydroxyestrone/16-hydroxyestrone ratio

  Up to 5 years

• Total PSA

  Up to 5 years

• Serum testosterone

  Up to 5 years

• IGF1:IGFBP-3 ratio

  Up to 5 years

• Tissue measures of messenger RNA of CYPs (CYP1A2, CYP1A1, CYP2B1, CYP3A)

  Up to 5 years

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive low-dose, nutritional-grade oral diindolylmethane (DIM) twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.

Drug: diindolylmethane; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: pharmacological study

Arm II

EXPERIMENTAL

Patients receive high-dose, nutritional-grade oral DIM twice daily as in arm I.

Drug: diindolylmethane; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: pharmacological study

Arm III

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 21-28 days in the absence of disease progression or unacceptable toxicity. Treatment may continue for up to 60 days, if surgery is delayed.

Drug: placebo; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

diindolylmethane DRUG

Given PO

Also known as: DIM

Arm I; Arm II

placebo DRUG

Given PO

Also known as: PLCB

Arm III

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Arm I; Arm II; Arm III

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II; Arm III

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I; Arm II; Arm III

Eligibility Criteria

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

Criteria: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1 or T2 a, b, or c (stage I-II disease) * Disease is confined within the prostate gland * Candidate for radical prostatectomy * ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100% * WBC normal * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL * AST =\< 1.5 times upper limit of normal * Creatinine =\< 2.0 mg/dL * Fertile patients must use effective contraception * No history of allergic reactions attributed to diindolylmethane (DIM\^), any of the inactive ingredients contained in BioResponse-DIM\^NG or placebo, or to compounds of similar chemical or biologic composition * No concurrent uncontrolled illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, No psychiatric illness or social situation that would preclude study compliance * No prior chemotherapy, hormonal therapy, brachytherapy, or external radiotherapy for prostate cancer * No concurrent nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, ibuprofen, naproxen sodium, or cyclooxygenase-2 inhibitors * No concurrent systemic therapy for any other cancer * No other concurrent investigational agents * No concurrent p450 inducers or inhibitors, including any of the following: Carbamazepine, Clarithromycin, Fluconazole, Fosphenytoin, Itraconazole, Ketoconazole, Phenobarbital, Phenytoin, Rifabutin, Rifampin * No concurrent finasteride or dutasteride * No more than 1 serving of cruciferous vegetables per day for duration of study * Cruciferous vegetables include the following: broccoli, cauliflower, brussels sprouts, cabbage, arugula, watercress, bok-choy, turnip greens, mustard greens, collard greens, rutabaga, Napa or Chinese cabbage, radishes, turnips, kohlrabi, and kale * Bilirubin normal * At least 21 days since prior surgery

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

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

Study Officials

• Jason Gee

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 4, 2015

Record last verified: 2013-05

Locations

US (1)