Prostate Cancer Clinical Trial
Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.
Full Description
OBJECTIVES:
Primary
Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer.
Secondary
Compare the disease-free survival and incidence of adverse events in patients treated with these regimens.
Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens.
Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens.
Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.
Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage
Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2
Gleason score 8, PSA 20-150 ng/mL, and any T stage
Gleason score 7, PSA 20-150 ng/mL, and any T stage
Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed
Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed
PSA ≤ 150 ng/mL
Cannot have been obtained during any of the following time points:
10-day period after prostate biopsy
After initiation of hormonal therapy
Within 30 days after discontinuation of finasteride
Within 90 days after discontinuation of dutasteride
No distant metastases by physical exam and bone scan
Equivocal bone scan findings allowed if plain films are negative
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,800/mm^3
Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)
Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Bilirubin ≤ 1.5 times ULN
Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)
No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
No transmural myocardial infarction within the past 6 months
No acute bacterial or fungal infection requiring intravenous antibiotics
No AIDS
No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80
No existing peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
At least 90 days since prior testosterone
Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
No prior systemic chemotherapy for prostate cancer
Prior chemotherapy for a different cancer is allowed
No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
Intensity modulated radiotherapy allowed
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There are 246 Locations for this study
Birmingham Alabama, 35294, United States
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85013, United States
Tucson Arizona, 85704, United States
Auburn California, 95603, United States
Burbank California, 91505, United States
Cameron Park California, 95682, United States
Carmichael California, 95608, United States
Chico California, 95926, United States
Concord California, 94524, United States
Fremont California, 94538, United States
Grass Valley California, 95945, United States
La Jolla California, 92093, United States
Modesto California, 95355, United States
Oakland California, 94609, United States
Rancho Mirage California, 92270, United States
Roseville California, 95661, United States
Sacramento California, 95815, United States
Sacramento California, 95817, United States
Sacramento California, 95819, United States
San Francisco California, 94118, United States
Torrance California, 90509, United States
Vacaville California, 95687, United States
Walnut Creek California, 94598, United States
Aurora Colorado, 80012, United States
Aurora Colorado, 80045, United States
Englewood Colorado, 80110, United States
Fort Collins Colorado, 80528, United States
Grand Junction Colorado, 81502, United States
Greeley Colorado, 80631, United States
Loveland Colorado, 80539, United States
Wheat Ridge Colorado, 80033, United States
Bridgeport Connecticut, 06606, United States
Bridgeport Connecticut, 06610, United States
New Haven Connecticut, 06511, United States
New Haven Connecticut, 06520, United States
Norwich Connecticut, 06360, United States
Norwich Connecticut, 06360, United States
Newark Delaware, 19713, United States
Gainesville Florida, 32610, United States
Panama City Florida, 32401, United States
Atlanta Georgia, 30303, United States
Atlanta Georgia, 30322, United States
Columbus Georgia, 31904, United States
Gainesville Georgia, 30501, United States
Savannah Georgia, 31403, United States
Honolulu Hawaii, 96813, United States
Boise Idaho, 83706, United States
Arlington Heights Illinois, 60005, United States
Decatur Illinois, 62526, United States
Elmhurst Illinois, 60126, United States
Park Ridge Illinois, 60068, United States
Rockford Illinois, 61108, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Anderson Indiana, 46016, United States
Fort Wayne Indiana, 46804, United States
Fort Wayne Indiana, 46805, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46219, United States
Ames Iowa, 50010, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Overland Park Kansas, 66210, United States
Louisville Kentucky, 40207, United States
Alexandria Louisiana, 71315, United States
New Orleans Louisiana, 70121, United States
Scarborough Maine, 04074, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21229, United States
Bethesda Maryland, 20814, United States
Boston Massachusetts, 02114, United States
Fall River Massachusetts, 02721, United States
Mansfield Massachusetts, 02048, United States
Peabody Massachusetts, 01960, United States
Quincy Massachusetts, 02169, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48910, United States
Royal Oak Michigan, 48073, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Pascagoula Mississippi, 39581, United States
Cape Girardeau Missouri, 63703, United States
Joplin Missouri, 64804, United States
Kansas City Missouri, 64131, United States
Kansas City Missouri, 64154, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
Las Vegas Nevada, 89135, United States
Concord New Hampshire, 03301, United States
Dover New Hampshire, 03820, United States
Exeter New Hampshire, 03833, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
Camden New Jersey, 08103, United States
Freehold New Jersey, 07728, United States
Marlton New Jersey, 08053, United States
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08903, United States
Voorhees New Jersey, 08043, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87109, United States
Albuquerque New Mexico, 87109, United States
Albuquerque New Mexico, 87131, United States
Santa Fe New Mexico, 87505, United States
Albany New York, 12206, United States
Cooperstown New York, 13326, United States
Rochester New York, 14642, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28232, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Gastonia North Carolina, 28053, United States
Greenville North Carolina, 27834, United States
High Point North Carolina, 27261, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Franklin Ohio, 45005, United States
Independence Ohio, 44131, United States
Kettering Ohio, 45429, United States
Lima Ohio, 45804, United States
Maumee Ohio, 43537, United States
Mayfield Heights Ohio, 44124, United States
Oregon Ohio, 43616, United States
Salem Ohio, 44460, United States
Sylvania Ohio, 43560, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43617, United States
Troy Ohio, 45373, United States
Wooster Ohio, 44691, United States
Wooster Ohio, 44691, United States
Xenia Ohio, 45385, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74136, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97239, United States
Salem Oregon, 97309, United States
The Dalles Oregon, 97058, United States
Abington Pennsylvania, 19001, United States
Beaver Pennsylvania, 15009, United States
Clairton Pennsylvania, 15025, United States
Clarion Pennsylvania, 16214, United States
Darby Pennsylvania, 19023, United States
Drexel Hill Pennsylvania, 19026, United States
Dunmore Pennsylvania, 18512, United States
Greensburg Pennsylvania, 15601, United States
Hershey Pennsylvania, 17033, United States
Johnstown Pennsylvania, 15901, United States
McKeesport Pennsylvania, 15132, United States
Moon Pennsylvania, 15108, United States
Natrona Heights Pennsylvania, 15065, United States
New Castle Pennsylvania, 16105, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15215, United States
Pittsburgh Pennsylvania, 15237, United States
Pittsburgh Pennsylvania, 15243, United States
Reading Pennsylvania, 19612, United States
Sayre Pennsylvania, 18840, United States
Sellersville Pennsylvania, 18960, United States
Seneca Pennsylvania, 16346, United States
Uniontown Pennsylvania, 15401, United States
Washington Pennsylvania, 15301, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
York Pennsylvania, 17405, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Knoxville Tennessee, 37916, United States
Bedford Texas, 76022, United States
Bryan Texas, 77802, United States
Dallas Texas, 75230, United States
Dallas Texas, 75237, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Sherman Texas, 75090, United States
Sugar Land Texas, 77479, United States
Murray Utah, 84157, United States
Ogden Utah, 84403, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05401, United States
Rutland Vermont, 05701, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23249, United States
Richmond Virginia, 23298, United States
Spokane Washington, 99204, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98431, United States
Charleston West Virginia, 25304, United States
Appleton Wisconsin, 54911, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Marinette Wisconsin, 54143, United States
Menomonee Falls Wisconsin, 53051, United States
Mequon Wisconsin, 53097, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Sheboygan Wisconsin, 53081, United States
Wausau Wisconsin, 54401, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1Y 4, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2W 1, Canada
Quebec City Quebec, G1R 2, Canada
Regina Saskatchewan, S4T 7, Canada
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