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

• ClinicalTrials.gov Identifier: NCT00888654
• Recruitment Status: Completed
• First Posted: April 27, 2009
• Results First Posted: March 30, 2015
• Last Update Posted: March 19, 2018
• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

Tracking Information

• First Submitted Date: April 24, 2009
• First Posted Date: April 27, 2009
• Results First Submitted Date: March 23, 2015
• Results First Posted Date: March 30, 2015
• Last Update Posted Date: March 19, 2018
• Study Start Date: August 2009
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 23, 2015): Mean Level of Diindolylmethane in Prostate Tissue After Treatment [ Time Frame: Within the first 24 months after radical prostatectomy. ]
• Original Primary Outcome Measures (submitted: April 24, 2009): Mean level of diindolylmethane in prostate tissue after treatment

Current Secondary Outcome Measures (submitted: March 14, 2018)

• Serum Levels of PSA, Testosterone, and Diindolylmethane [ Time Frame: Pre and post radical prostatectomy ]
  Serum levels of PSA, testosterone, and diindolylmethane (DIM)
• Levels of Androgen Receptor in Prostate Tissue [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: April 24, 2009)

• Pre- and post-treatment serum levels of PSA, testosterone, and diindolylmethane
• Pre- and post-treatment levels of androgen receptor, NF-kB, and PSA in prostate tissue

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
• 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

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Drug: B-Dim
  B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)
  Other Name: 3,3'-Diindolylmethane
• Procedure: Radical Prosatectomy
  Other Name: therapeutic conventional surgery

Study Arms

Experimental: B-Dim, Radical Prosatectomy

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

Radical Prostatectomy

Interventions:

• Drug: B-Dim
• Procedure: Radical Prosatectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2018): 41
• Original Estimated Enrollment (submitted: April 24, 2009): 30
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00888654
• Other Study ID Numbers: CDR0000641168; P30CA022453 ( U.S. NIH Grant/Contract ); WSU-2007-128
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
• Study Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Elisabeth I. Heath, MD; Barbara Ann Karmanos Cancer Institute

• PRS Account: Barbara Ann Karmanos Cancer Institute
• Verification Date: November 2017