Phase 2 N=41 Treatment

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

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00888654 ↗

Enrolled (actual)

Serious AEs

4.9%

Results posted

Mar 2015

Primary outcome: Primary: Mean Level of Diindolylmethane in Prostate Tissue After Treatment — 14.2 ng/g

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: B-Dim (Drug); Radical Prosatectomy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Barbara Ann Karmanos Cancer Institute
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Level of Diindolylmethane in Prostate Tissue After Treatment	14.2	—
SECONDARY Serum Levels of PSA, Testosterone, and Diindolylmethane	6.4; 5.8; 301; 388; 0.0; 7.5	—
SECONDARY Levels of Androgen Receptor in Prostate Tissue	278; 245	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00888654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.