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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bicalutamide

eflornithine

oral eflornithine placebo

oral bicalutamide placebo

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00086736

First Posted

July 8, 2004

Last Updated

November 17, 2013

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00086736

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

November 2001 (undefined)

Primary Completion Date

November 2003 (Actual)

Study Completion Date

November 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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. 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. PROJECTED ACCRUAL: A total of 44 patients (11 per treatment arm) will be accrued for this study within 11 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm II

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm III

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm IV

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

bicalutamide

Intervention Type

Drug

Intervention Name(s)

eflornithine

Intervention Type

Drug

Intervention Name(s)

oral eflornithine placebo

Intervention Type

Drug

Intervention Name(s)

oral bicalutamide placebo

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks after surgical intervention

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald A. Urban, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham Comprehensive Cancer Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294-3300

Country

United States

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial