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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight prostate cancer by stopping the adrenal glands from producing androgens. Combining eflornithine with bicalutamide may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for localized prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bicalutamide; Eflornithine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer

• Localized disease

• Paraffin blocks from diagnostic biopsies available

• Planning to undergo brachytherapy or prostatectomy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 10.0 g/dL

• WBC ≥ 3,500/mm^3

• Platelet count ≥ 125,000/mm^3

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

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