Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
OBJECTIVES:
Primary
- Compare the rate of 3-year biochemical progression-free survival (bPFS) in patients
with high-risk, clinically localized prostate cancer treated with radical prostatectomy
with vs without neoadjuvant chemohormonal therapy comprising docetaxel and
androgen-deprivation therapy with leuprolide acetate or goserelin.
Secondary
- Compare the 5-year bPFS rate, bPFS, disease progression, disease-free survival, and
overall survival of patients treated with these regimens.
- Determine the safety and tolerability of neoadjuvant docetaxel and androgen-deprivation
therapy in these patients.
- Compare the time to clinically apparent local disease recurrence and metastatic disease
in patients treated with these regimens.
- Compare pathologic tumor stage, frequency of lymph node metastases, and positive margin
rates in patients treated with these regimens.
- Determine if changes in serum testosterone levels will predict bPFS in these patients.
- Determine, prospectively, whether prostate-specific antigen doubling time is a
surrogate endpoint for time to clinical metastases and overall survival in these
patients.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
nomogram-predicted biochemical progression-free survival at 5 years (0-20.9% vs 21-39.9% vs
40-59.9% vs ≥ 60%) and androgen-deprivation therapy in the past 3 months (no vs yes).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive goserelin subcutaneously or leuprolide acetate intramuscularly
once every 4 or 12 weeks for 18-24 weeks (measured from the date of starting
docetaxel). They also receive docetaxel IV over 1 hour on day 1. Treatment with
docetaxel repeats every 3 weeks for up to 6 courses. Within 60 days after completion of
chemohormonal therapy, patients undergo radical prostatectomy with staging pelvic
lymphadenectomy.
- Arm II: Within 60 days after randomization, patients undergo radical prostatectomy with
staging pelvic lymphadenectomy.
After completion of study therapy, patients are followed at 1 and 3 months and then
periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
3-year biochemical progression-free survival (bPFS) rate
No
James A. Eastham, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
Unspecified
CDR0000526353
NCT00430183
December 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Naval Medical Center - San Diego | San Diego, California 92134-3202 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Mercy Fitzgerald Hospital | Darby, Pennsylvania 19023 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Somerset Medical Center | Somerville, New Jersey 08876 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Pennington Cancer Center at Baton Rouge General | Baton Rouge, Louisiana 70806 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Kaiser Permanente Health Care - Portland | Portland, Oregon 97232 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Mountainview Medical | Berlin, Vermont 05602 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
Denver Health Medical Center | Denver, Colorado 80204-4507 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
St. Francis Hospital | Federal Way, Washington 98003 |
Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland, Washington 98034-3013 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Duke Cancer Institute | Durham, North Carolina 27710 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
Rockwood Clinic Cancer Treatment Center | Spokane, Washington 99204-2967 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Berkshire Hematology Oncology, PC | Pittsfield, Massachusetts 01201 |
Lynchburg Hematology-Oncology Clinic | Lynchburg, Virginia 24501 |
Tahoe Forest Cancer Center | Truckee, California 96161 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
Pacific Cancer Institute - Maui | Wailuku, Hawaii 96793 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Bay Area Hospital | Coos Bay, Oregon 97420 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Cleveland Clinic Florida - Weston | Weston, Florida 33331 |
Veterans Affairs Medical Center - West Haven | West Haven, Connecticut 06516 |
Hematology Oncology Associates, PC | Albuquerque, New Mexico 87106 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
Mount Carmel Regional Cancer Center | Pittsburg, Kansas 66762 |
Shaw Regional Cancer Center | Edwards, Colorado 81632 |
Tufts Medical Center Cancer Center | Boston, Massachusetts 02111 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Valley View Hospital Cancer Center | Glenwood Springs, Colorado 81601 |
Castle Medical Center | Kailua, Hawaii 96734 |
Kauai Medical Clinic | Lihue, Hawaii 96766 |
Central Dupage Cancer Center | Warrenville, Illinois 60555 |
Hays Medical Center | Hays, Kansas 67601 |
Hutchinson Hospital Corporation | Hutchinson, Kansas 67502 |
Lakeside Hospital | Omaha, Nebraska 68130 |
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | Albuquerque, New Mexico 87110 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Pacific Medical Center | Seattle, Washington 98104 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
St. Rose Ambulatory and Surgery Center | Great Bend, Kansas 67530 |
Kansas City Cancer Centers - West | Kansas City, Kansas 66112 |
Kansas City Cancer Center - Shawnee Mission | Shawnee Mission, Kansas 66204 |
Kansas City Cancer Centers - East | Lee's Summit, Missouri 64064 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Idaho Urologic Institute, PA | Meridian, Idaho 83642 |
Delnor Hospital - Geneva | Geneva, Illinois 60134 |
Sutter Pacific Medical Foundation | Santa Rosa, California 95403 |
Cleveland Regional Medical Center | Shelby, North Carolina 28150 |
Benefis Sletten Cancer Institute | Great Falls, Montana 59405 |
Carolinas Medical Center - Union | Monroe, North Carolina 28112 |
Seattle Cancer Care Alliance at EvergreenHealth | Kirkland, Washington 98034 |