Prostate Diseases |
Benign Prostatic Hypertrophy; Prostate Disease; Prostate Enlargement; Prostatitis |
Clinical Trial: Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
This study is currently recruiting patients.
Purpose
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing 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 plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer | Drug: bicalutamide Drug: goserelin Drug: mitoxantrone Drug: prednisone Procedure: adjuvant therapy Procedure: antiandrogen therapy Procedure: chemotherapy Procedure: endocrine therapy Procedure: hormone therapy Procedure: radiation therapy Procedure: releasing factor agonist therapy | Phase III |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Adjuvant Androgen Deprivation Therapy With or Without Mitoxantrone and Prednisone After Radical Prostatectomy in Patients With High-Risk Adenocarcinoma of the Prostate
OBJECTIVES:
- Compare the overall and disease-free survival of patients with high-risk adenocarcinoma of the prostate treated with adjuvant androgen deprivation therapy with or without mitoxantrone and prednisone after radical prostatectomy.
- Compare the qualitative and quantitative toxic effects of these regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I:Patients receive goserelin subcutaneously once every 12 weeks and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
- Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone. Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I) or after completion of chemotherapy (arm II), at the discretion of the physician, in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for up to 13 years.
PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for this study within 9.5 years.
Eligibility
Ages Eligible for Study: 30 Years - 85 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage T1-T2 adenocarcinoma of the prostate before radical prostatectomy and lymph node dissection
- Must have undergone prostatectomy within the past 120 days
- Must meet at least 1 of the following pathologic criteria:
- Gleason sum at least 8
- pT3b (seminal vesicle), pT4, or N1
- Gleason sum of 7 and positive margin
- Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA level greater than 10 ng/mL and Gleason score greater than 6
- Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy prior to study)
- No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at clinical diagnosis
- No distant metastatic disease
PATIENT CHARACTERISTICS: Age:
- 30 to 85
Performance status:
- SWOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No uncontrolled congestive heart failure
- If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram
Other:
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical prostatectomy allowed
- Other concurrent adjuvant hormonal therapy allowed if initiated prior to study
- Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed
Radiotherapy:
- No prior radiotherapy
- No concurrent whole pelvis irradiation
- Concurrent radiotherapy allowed at the discretion of the physician
Surgery:
- See Disease Characteristics
- See Endocrine therapy
- Recovered from prior surgery
Other:
- No other prior or concurrent therapy for adenocarcinoma of the prostate
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
University of California Davis Cancer Center, Sacramento, California, 95817, United States; Recruiting
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford, Illinois, 61108, United States; Recruiting
La Grange Oncology Associates, La Grange, Illinois, 60525, United States; Recruiting
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7390, United States; Recruiting
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0946, United States; Recruiting
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Minnesota
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Elmhurst Hospital Center, Elmhurst, New York, 11373, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Lenoir Memorial Cancer Center, Kinston, North Carolina, 28503-1678, United States; Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Veterans Affairs Medical Center - Dallas, Dallas, Texas, 75219, United States; Recruiting
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, 23510-1115, United States; Recruiting
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
L. Michael Glode, MD, Study Chair, University of Colorado Cancer Center
Nancy Ann Dawson, MD, Study Chair, University of Maryland Greenebaum Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2005
Last Updated: March 28, 2005
Record first received: December 10, 1999
ClinicalTrials.gov Identifier: NCT00004124
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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