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

NCT00086736 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000353198UAB-9921UAB-F990728039
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Mean difference in levels of Polyamine spermine, polyamine putrescine, and spermidine between subjects in each of the 4 groups

  4 weeks after surgical intervention

Study Arms (4)

Arm I

EXPERIMENTAL

Patients receive oral eflornithine and oral bicalutamide once daily for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29.

Drug: bicalutamide; Drug: eflornithine

Arm II

EXPERIMENTAL

Patients receive oral eflornithine and oral bicalutamide placebo once daily for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29.

Drug: eflornithine; Drug: oral bicalutamide placebo

Arm III

EXPERIMENTAL

Patients receive oral eflornithine placebo and oral bicalutamide once daily for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29.

Drug: bicalutamide; Drug: oral eflornithine placebo

Arm IV

EXPERIMENTAL

Patients receive oral eflornithine placebo and oral bicalutamide placebo once daily for 28 days in the absence of unacceptable toxicity. Patients then undergo either prostatectomy or brachytherapy, as determined by the patient, on day 29.

Drug: oral eflornithine placebo; Drug: oral bicalutamide placebo

Interventions

bicalutamide DRUG

Arm I; Arm III

eflornithine DRUG

Arm I; Arm II

oral eflornithine placebo DRUG

Arm III; Arm IV

oral bicalutamide placebo DRUG

Arm II; Arm IV

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Eflornithine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Donald A. Urban, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: November 1, 2001
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: November 19, 2013

Record last verified: 2013-07

Locations

US (1)