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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UAB-9921 UAB-F990728039, NCT00086736

Objectives

1. 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.
2. 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.
3. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed prostate cancer
  • Localized disease



• 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

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

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

• Creatinine ≤ 2.0 mg/dL

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

UAB Comprehensive Cancer Center

Donald Urban, MD, Principal investigator		Ph: 205-975-0088

Registry Information
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
Trial Start Date		2001-11-01
Registered in ClinicalTrials.gov		NCT00086736
Date Submitted to PDQ		2004-01-14
Information Last Verified		2004-08-30
NCI Grant/Contract Number		P30-CA13148, N01-CN35577-02

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