Prostate Cancer Clinical Trial

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.

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Full Description

OBJECTIVES:

Compare time to objective progression in patients with prostate cancer and a rising prostate-specific antigen (PSA) after androgen suppression when treated with second-line hormonal therapy (ketoconazole and hydrocortisone) vs combination chemotherapy (docetaxel and estramustine).
Compare time to PSA progression and correlate this with time to objective progression in patients treated with these regimens.
Compare the quality of life in patients treated with these regimens.
Compare overall survival of patients treated with these regimens.
Compare the natural history of progression in patients treated with these regimens.
Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of apoptopic biomarkers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive oral estramustine three times daily on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and then annually for up to 10 years or until beginning of first non-protocol therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this study within 4 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate that was continuously treated with androgen suppression
Rising prostate-specific antigen (PSA), defined as PSA > 5 ng/mL, rising on 2 consecutive measurements at least 4 weeks apart
Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis

Patients previously treated with antiandrogen or glucocorticoid therapy must meet the following criteria:

Must show a continued rise in PSA after stopping antiandrogen (flutamide, bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)

At least 4 weeks continued rise in PSA after flutamide or nilutamide (6 weeks for bicalutamide)

Testosterone less than 50 ng/dL

Patients who have not undergone surgical castration must continue primary androgen suppression to maintain castrate levels of testosterone
No progressive or measurable local or metastatic disease (including bone metastases)

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 2,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

SGOT no greater than 2 times upper limit of normal
Bilirubin no greater than 1.5 mg/dL

Renal:

Creatinine no greater than 1.7 mg/dL

Cardiovascular:

No American Heart Association class III or IV heart disease
No uncontrolled congestive heart failure
No life-threatening cardiac arrhythmias

Other:

Fertile patients must use effective contraception
No other prior malignancy unless curatively treated and disease-free for appropriate time period for specific cancer
No preexisting peripheral neuropathy greater than grade 1
No known hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 5 years since prior systemic chemotherapy

Endocrine therapy:

See Disease Characteristics
At least 4 weeks since prior hydrocortisone
No prior ketoconazole

Radiotherapy:

At least 28 days since prior radiotherapy to primary site
No prior palliative radiotherapy
No concurrent radiotherapy

Surgery:

See Disease Characteristics

Other:

Recovered form prior therapy
At least 7 days since prior parenteral antibiotics for active infection
No concurrent digitalis
No concurrent H_2 blockers or proton pump inhibitors (arm I only)
Concurrent bisphosphonates allowed provided they were initiated prior to study therapy

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Study ID:

NCT00027859

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 90 Locations for this study

See Locations Near You

Comprehensive Cancer Institute
Huntsville Alabama, 35801, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Veterans Affairs Medical Center - Little Rock
Little Rock Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California, 94553, United States
Naval Medical Center - San Diego
San Diego California, 92134, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Medical Center of Aurora - South Campus
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
Rocky Mountain Cancer Centers - Denver Rose
Denver Colorado, 80220, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80112, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80501, United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
Rocky Mountain Cancer Centers - Thornton
Thornton Colorado, 80221, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood Florida, 33021, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
MBCCOP - Hawaii
Honolulu Hawaii, 96813, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines
Hines Illinois, 60141, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
West Suburban Center for Cancer Care
River Forest Illinois, 60305, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40502, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71101, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph Michigan, 49085, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett New Hampshire, 03106, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
Cape Fear Valley Health System
Fayetteville North Carolina, 28302, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro North Carolina, 27534, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
Oklahoma University Medical Center
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Abramson Cancer Center at the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina, 29401, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
Veterans Affairs Medical Center - Amarillo
Amarillo Texas, 79106, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78229, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
Martha Jefferson Hospital
Charlottesville Virginia, 22902, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke Virginia, 24014, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
St. Mary's Medical Center
Huntington West Virginia, 25701, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54307, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Study ID:

NCT00027859

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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