Status:
COMPLETED
Diindolylmethane in Treating Patients With Stage I or Stage II Prostate Cancer Undergoing Radical Prostatectomy
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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 tr...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00888654
Start Date
August 1 2009
End Date
April 1 2014
Last Update
March 19 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
2
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202