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Phase II Randomized Study of Neoadjuvant Eflornithine and Bicalutamide Versus Eflornithine Alone Versus Bicalutamide Alone Versus No Neoadjuvant Therapy in Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI
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UAB-9921 UAB-F990728039, NCT00086736
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Objectives - Compare levels of polyamine spermine, polyamine putrescine, and spermidine in patients with localized prostate cancer undergoing brachytherapy or radical prostatectomy and treated with neoadjuvant eflornithine and bicalutamide vs eflornithine alone vs bicalutamide alone vs no neoadjuvant therapy.
- Compare the expression of surrogate biomarkers (i.e., serum prostate-specific antigen, tissue levels of proliferating cell nuclear antigen, Ki67, and TGF-alpha, apoptosis assays [ICH-PARP and TUNEL], and cytomorphometric indices) in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed prostate cancer
- Paraffin blocks from diagnostic biopsies available
- Planning to undergo brachytherapy or prostatectomy
Prior/Concurrent Therapy:
Biologic therapy - No concurrent immunotherapy
Chemotherapy - No other concurrent chemotherapy
Endocrine therapy - More than 1 year since prior antiandrogen, luteinizing hormone-releasing hormone (LHRH) agonist, bicalutamide, finasteride, or diethylstilbestrol
- No other concurrent antiandrogen, LHRH agonist, finasteride, or diethylstilbestrol
Radiotherapy - See Disease Characteristics
- No other concurrent radiotherapy
Surgery - See Disease Characteristics
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Hemoglobin ≥ 10.0 g/dL
- WBC ≥ 3,500/mm3
- Platelet count ≥ 125,000/mm3
Hepatic - Bilirubin ≤ 2.0 mg/dL
- SGOT and SGPT ≤ 2 times normal
- No history of liver disease (e.g., hepatitis, cirrhosis, or jaundice)
Renal Cardiovascular - No symptomatic coronary artery disease
- No uncontrolled hypertension
- No acute myocardial infarction within the past year
Other - Fertile patients must use effective contraception
- No more than 10 decibels baseline hearing loss at any frequency by full bilateral audiometry within the past month
- No hypersensitivity to eflornithine or bicalutamide
- No other prior or active malignancy except nonmelanoma skin cancer or other cancer curatively treated at least 5 years ago with no evidence of recurrent or residual disease
- No concurrent acute or chronic medical or psychiatric condition that would preclude study participation
Expected Enrollment A total of 44 patients (11 per treatment arm) will be accrued for this study within 11 months. Outline This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to Gleason score (< 7 vs ≥ 7). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive oral eflornithine and oral bicalutamide once daily.
- Arm II: Patients receive oral eflornithine and oral bicalutamide placebo once daily.
- Arm III: Patients receive oral eflornithine placebo and oral bicalutamide once daily.
- Arm IV: Patients receive oral eflornithine placebo and oral bicalutamide placebo once daily.
In all arms, treatment continues for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29. Patients are followed at 4 weeks.
Trial Contact Information
Trial Lead Organizations Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham ![](/images/spacer.gif) | ![](/images/spacer.gif) | ![](/images/spacer.gif) | Donald Urban, MD, Principal investigator | ![](/images/spacer.gif) | | ![](/images/spacer.gif) |
Registry Information | ![](/images/spacer.gif) | Official Title | | A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients with Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy: Modulation of Tissue and Molecular Biomarkers in Human Prostate Tissue Serum | ![](/images/spacer.gif) | Trial Start Date | | 2001-11-01 | ![](/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00086736 | ![](/images/spacer.gif) | Date Submitted to PDQ | | 2004-01-14 | ![](/images/spacer.gif) | Information Last Verified | | 2004-08-30 | ![](/images/spacer.gif) | NCI Grant/Contract Number | | P30-CA13148, N01-CN35577-02 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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