Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030654
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 10, 2017
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Southwest Oncology Group
NRG Oncology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Drug: flutamide Drug: ketoconazole Drug: paclitaxel Drug: releasing hormone agonist therapy Drug: vinblastine sulfate Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy
Study Start Date : October 2002
Actual Primary Completion Date : February 4, 2005
Actual Study Completion Date : February 4, 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Androgen blockade + immediate chemotherapy
Androgen blockade with immediate chemotherapy
Drug: bicalutamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Drug: flutamide Drug: ketoconazole Drug: paclitaxel Drug: releasing hormone agonist therapy Drug: vinblastine sulfate
Experimental: Androgen blockade + delayed chemotherapy
Androgen blockade with delayed chemotherapy
Drug: bicalutamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Drug: flutamide Drug: ketoconazole Drug: paclitaxel Drug: releasing hormone agonist therapy Drug: vinblastine sulfate

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of randomization to the date of death due to any cause ]

Secondary Outcome Measures :
  1. Biochemical control [ Time Frame: From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks ]
  2. Time to Clinical Failure [ Time Frame: Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks ]
  3. Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities [ Time Frame: From the beginning of treatment to 90 days post treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of adenocarcinoma of the prostate

    • Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by a rising prostate-specific antigen level of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32 weeks or less
    • No clinical or radiographic evidence of disease
    • Original Gleason score of at least 7 OR Gleason score of 6 with capsular penetration or positive seminal vesicles or lymph nodes
  • No metastases



  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects


  • Bilirubin no greater than 1.5 mg/dL
  • AST/ALT no greater than 1.5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL
  • Blood Urea Nitrogen (BUN) no greater than 1.2 times normal


  • No symptomatic heart disease
  • No history of myocardial infarction
  • No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism)


  • No other major medical or psychiatric illness that would preclude study entry
  • No other prior or concurrent invasive malignancy within the past 5 years except superficial skin cancer
  • No history of esophageal varices
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 6 weeks since prior vaccine therapy


  • At least 5 years since prior chemotherapy

Endocrine therapy:

  • Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed
  • At least 1 year since prior androgen therapy


  • See Disease Characteristics
  • At least 5 years since prior radiotherapy to sites other than prostate


  • See Disease Characteristics


  • Concurrent warfarin allowed
  • Concurrent bisphosphonate therapy initiated prior to or after randomization allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030654

  Hide Study Locations
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States, 72205
United States, California
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
Medical Center of Aurora - South Campus
Aurora, Colorado, United States, 80012-0000
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
St. Joseph Hospital
Denver, Colorado, United States, 80218-1191
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers - Denver Rose
Denver, Colorado, United States, 80220
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
Swedish Medical Center
Englewood, Colorado, United States, 80112
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, United States, 80221
United States, Florida
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
United States, Iowa
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kansas
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101-4295
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0010
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Nebraska
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
United States, New Mexico
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
Akron General's McDowell Cancer Center
Akron, Ohio, United States, 44302
Akron City Hospital at Summa Health System
Akron, Ohio, United States, 44304
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428-1002
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oregon
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, Pennsylvania
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
United States, South Carolina
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Erlanger Cancer Center
Chattanooga, Tennessee, United States, 37403
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States, 79106
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Southwest Oncology Group
NRG Oncology
Study Chair: Kenneth J. Pienta, MD, FACP University of Michigan Cancer Center
Study Chair: Naomi S. Balzer-Haas, MD Fox Chase Cancer Center
Study Chair: Arif Hussain, MD University of Maryland Greenebaum Cancer Center
Study Chair: Gregory P. Swanson, MD Deaconess Medical Center, Spokane, Washington
Study Chair: Primo N. Lara, MD University of California, Davis

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00030654     History of Changes
Other Study ID Numbers: RTOG-P-0014
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Liposomal doxorubicin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists