Prostate Cancer Clinical Trial
S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
Summary
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.
Full Description
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.
Compare the prostate-specific antigen (PSA) progression-free survival rate in patient treated with these regimens.
Determine whether PSA progression is a surrogate endpoint for survival or disease-free survival 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 13 weeks (8 injections total) 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 offered the possibility to participate in biomarker research by allowing their tissue/blood to be studied.
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 Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage T1-T3 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:
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 HIV positivity
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
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There are 192 Locations for this study
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Glendale Arizona, 85306, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85006, United States
Little Rock Arkansas, 72205, United States
Springdale Arkansas, 72764, United States
Berkeley California, 94704, United States
Burlingame California, 94010, United States
Greenbrae California, 94904, United States
Greenbrae California, 94904, United States
Greenbrae California, 94904, United States
San Diego California, 92134, United States
San Francisco California, 94110, United States
San Francisco California, 94115, United States
San Francisco California, 94118, United States
San Francisco California, 94121, United States
Santa Barbara California, 93105, United States
Santa Barbara California, 93105, United States
Santa Barbara California, 93105, United States
Solvang California, 93463, United States
Vallejo California, 94589, United States
Colorado Springs Colorado, 80909, United States
Greeley Colorado, 80631, United States
Loveland Colorado, 80539, United States
Norwich Connecticut, 06360, United States
Stamford Connecticut, 06904, United States
Washington District of Columbia, 20007, United States
Augusta Georgia, 30912, United States
Gainesville Georgia, 30501, United States
Honolulu Hawaii, 96859, United States
Alton Illinois, 62002, United States
Aurora Illinois, 60507, United States
Barrington Illinois, 60010, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60616, United States
Chicago Illinois, 60625, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60657, United States
Downers Grove Illinois, 60515, United States
Evanston Illinois, 60201, United States
Hines Illinois, 60141, United States
Joliet Illinois, 60432, United States
Joliet Illinois, 60435, United States
La Grange Illinois, 60525, United States
Libertyville Illinois, 60048, United States
Maywood Illinois, 60153, United States
Mount Vernon Illinois, 62864, United States
Niles Illinois, 60714, United States
Normal Illinois, 61761, United States
Park Ridge Illinois, 60068, United States
Skokie Illinois, 60076, United States
Skokie Illinois, 60076, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Evansville Indiana, 47714, United States
Indianapolis Indiana, 46202, United States
Michigan City Indiana, 46360, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Waterloo Iowa, 50702, United States
Waterloo Iowa, 50702, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kansas City Kansas, 64128, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Lexington Kentucky, 40536, United States
Monroe Louisiana, 71210, United States
Shreveport Louisiana, 71101, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Burlington Massachusetts, 01805, United States
Worcester Massachusetts, 01605, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Big Rapids Michigan, 49307, United States
Detroit Michigan, 48201, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Grosse Pointe Woods Michigan, 48236, United States
Holland Michigan, 49423, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48909, United States
Muskegon Michigan, 49442, United States
Petoskey Michigan, 49770, United States
Port Huron Michigan, 48060, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Alexandria Minnesota, 56308, United States
Brainerd Minnesota, 56401, United States
Brainerd Minnesota, 56401, United States
Fergus Falls Minnesota, 56537, United States
Montevideo Minnesota, 56265, United States
Saint Cloud Minnesota, 56303, United States
Saint Cloud Minnesota, 56303, United States
Sartell Minnesota, 56377, United States
Cape Girardeau Missouri, 63701, United States
Cape Girardeau Missouri, 63701, United States
Chesterfield Missouri, 63017, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89106, United States
Keene New Hampshire, 03431, United States
Laconia New Hampshire, 03246, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
Rochester New Hampshire, 03867, United States
Hamilton New Jersey, 08690, United States
Montclair New Jersey, 07042, United States
Morristown New Jersey, 07962, United States
New Brunswick New Jersey, 08903, United States
Albuquerque New Mexico, 87131, United States
Brooklyn New York, 11209, United States
Buffalo New York, 14215, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Kinston North Carolina, 28501, United States
Rutherfordton North Carolina, 28139, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Akron Ohio, 44309, United States
Bryan Ohio, 43506, United States
Cleveland Ohio, 44195, United States
Independence Ohio, 44131, United States
Lima Ohio, 45801, United States
Wooster Ohio, 44691, United States
Youngstown Ohio, 44501, United States
Oklahoma City Oklahoma, 73104, United States
Bend Oregon, 97701, United States
Gresham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Tualatin Oregon, 97062, United States
Allentown Pennsylvania, 18105, United States
Harrisburg Pennsylvania, 17105, United States
Pittsburgh Pennsylvania, 15232, United States
Aiken South Carolina, 29801, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Berlin Vermont, 05602, United States
Burlington Vermont, 05401, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Mount Vernon Washington, 98273, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Sedro-Woolley Washington, 98284, United States
Spokane Washington, 99202, United States
Spokane Washington, 99204, United States
Tacoma Washington, 98431, United States
Vancouver Washington, 98668, United States
Wenatchee Washington, 98801, United States
Yakima Washington, 98902, United States
Appleton Wisconsin, 54911, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Madison Wisconsin, 53717, United States
Madison Wisconsin, 53792, United States
Marinette Wisconsin, 54143, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
Wausau Wisconsin, 54401, United States
Sheridan Wyoming, 82801, United States
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