Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00030654
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.
Secondary
* Compare biochemical control in patients treated with these regimens.
* Determine the toxicity of these regimens in these patients.
* Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens:
* Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen G: With approval from the protocol chair, patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50% response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions.
* Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical failure, at which time patients receive chemotherapy as in arm I. Patients who have a response may continue to receive chemotherapy beyond 4 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Androgen blockade + immediate chemotherapy docetaxel Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy doxorubicin hydrochloride Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy ketoconazole Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy bicalutamide Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy estramustine phosphate sodium Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy flutamide Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy paclitaxel Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy releasing hormone agonist therapy Androgen blockade with immediate chemotherapy Androgen blockade + immediate chemotherapy vinblastine sulfate Androgen blockade with immediate chemotherapy Androgen blockade + delayed chemotherapy bicalutamide Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy docetaxel Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy doxorubicin hydrochloride Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy flutamide Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy estramustine phosphate sodium Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy paclitaxel Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy releasing hormone agonist therapy Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy vinblastine sulfate Androgen blockade with delayed chemotherapy Androgen blockade + delayed chemotherapy ketoconazole Androgen blockade with delayed chemotherapy
- Primary Outcome Measures
Name Time Method Overall Survival From date of randomization to the date of death due to any cause
- Secondary Outcome Measures
Name Time Method Biochemical control From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks Time to Clinical Failure Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities From the beginning of treatment to 90 days post treatment
Trial Locations
- Locations (78)
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Medical Center of Aurora - South Campus
🇺🇸Aurora, Colorado, United States
Veterans Affairs Medical Center - Little Rock
🇺🇸Little Rock, Arkansas, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers - Thornton
🇺🇸Thornton, Colorado, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Instituto de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Erlanger Cancer Center
🇺🇸Chattanooga, Tennessee, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
San Juan City Hospital
🇵🇷San Juan, Puerto Rico
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Shands Cancer Center at the University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Veterans Affairs Medical Center - Hines
🇺🇸Hines, Illinois, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Wendt Regional Cancer Center at Finley Hospital
🇺🇸Dubuque, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Midlands Cancer Center at Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Akron City Hospital at Summa Health System
🇺🇸Akron, Ohio, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Akron General's McDowell Cancer Center
🇺🇸Akron, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Cancer Care Center, Incorporated
🇺🇸Salem, Ohio, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
Lipson Cancer and Blood Center at Rochester General Hospital
🇺🇸Rochester, New York, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
All Saints Cancer Center at All Saints Healthcare
🇺🇸Racine, Wisconsin, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States