Androgen Receptor Modulation Phase II, Randomized Study of MK-2206 - Bicalutamide Combination in Patients With Rising PSA at High-Risk of Progression After Primary Therapy
PRIMARY OBJECTIVES:
I. To compare the two regimens on the proportion of patients with undetectable
prostate-specific antigen (PSA) level (< 0.2 ng/mL) at 44 weeks.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients with PSA decline >= 85% at 44 weeks on the
combination therapy arm compared to that of bicalutamide monotherapy arm.
II. To assess the distribution of best PSA response in each study arm. III. To assess the
time to PSA progression in each arm of the study. IV. To assess the time to PSA nadir in
each arm of the study. V. To assess the duration of PSA response in each arm of the study.
VI. To characterize the PSA slope pre-study, during treatment, and off treatment.
VII. To evaluate the safety and tolerability of MK-2206 (Akt inhibitor MK2206) in this
patient population.
VIII. To determine whether Gleason score has any effect on PSA response to treatment.
IX. To determine whether prior hormonal therapy has any effect on PSA response to treatment.
TERTIARY OBJECTIVES:
I. Samples of the primary tumor specimen will be retrieved for banking and future analysis
of the molecular profile of the primary prostate cancer (PC) tissues with emphasis on the
androgen receptor (AR) and protein kinase B (Akt) upstream and downstream signaling
pathways.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo observation on weeks 1-12. Patients then receive bicalutamide*
orally (PO) once daily (QD) on weeks 13-44. Patients with a PSA decline of >= 50% may
continue on bicalutamide until week 72 in the absence of disease progression or unacceptable
toxicity.
ARM II: Patients receive Akt inhibitor MK2206** PO once per week on weeks 1-44 and
bicalutamide* PO QD on weeks 13-44. Patients with a PSA decline of >= 50% may continue on
MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable
toxicity.
NOTE: *Patients may begin bicalutamide on weeks 4-11 if the disease worsens.
NOTE: **Patients on Akt inhibitor MK2206 with a PSA < 0.2 ng/mL by week 12 do not receive
bicalutamide until PSA rises to >= 0.2 ng/mL.
After completion of study therapy, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then every year for up to 10 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with undetectable PSA level (< 0.2 ng/mL)
44 weeks
No
Anna Ferrari
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-02648
NCT01251861
December 2010
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Mayo Clinic | Rochester, Minnesota 55905 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Hurley Medical Center | Flint, Michigan 48503 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Beth Israel Medical Center | New York, New York 10003 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Trinity Medical Center | Moline, Illinois 61265-1291 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Bixby Medical Center | Adrian, Michigan 49221 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Saint Luke's Hospital | Maumee, Ohio 43537 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Swedish American Hospital | Rockford, Illinois 61104 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
Longmont United Hospital | Longmont, Colorado 80501 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Memorial Medical Center | Springfield, Illinois 62781 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Hennepin County Medical Center | Minneapolis, Minnesota |
VA Palo Alto Health Care System | Palo Alto, California 94304-1207 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Emory University | Atlanta, Georgia 30322 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Tufts Medical Center | Boston, Massachusetts 02111 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Hematology Oncology Associates | Albuquerque, New Mexico 87106 |
Butler Memorial Hospital | Butler, Pennsylvania 16001 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Veterans Administration Medical Center | Decatur, Georgia 30033 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
John H Stroger Jr Hospital of Cook County | Chicago, Illinois 60612-3785 |
Evanston CCOP-NorthShore University HealthSystem | Evanston, Illinois 60201 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis, Indiana 46202 |
Wishard Hospital | Indianapolis, Indiana 46202 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
McFarland Clinic | Ames, Iowa 50010 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Hickman Cancer Center | Adrian, Michigan 49221 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Veterans Adminstration New Jersey Health Care System | East Orange, New Jersey 07018-1095 |
Memorial Medical Center - Las Cruces | Las Cruces, New Mexico 88011 |
New York University Langone Medical Center | New York, New York 10016 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Saint Charles Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
Mercy Cancer Center at Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
University of Toledo | Toledo, Ohio 43614 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
The Memorial Hospital at Easton | Easton, Maryland 21601 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Community Health Partners Regional Medical Center | Elyria, Ohio 44035 |
Saint Mary Medical and Regional Cancer Center | Langhorne, Pennsylvania 19047 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Hinsdale Hematology Oncology Associates Incorporated | Hinsdale, Illinois 60521 |
Saint Nicholas Hospital | Madison, Wisconsin 53715 |
Central Indiana Cancer Centers - Indianapolis | Indianapolis, Indiana 46227 |
Stanford University Hospitals and Clinics | Stanford, California 94305 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Marie Yeager Cancer Center | Saint Joseph, Michigan 49085 |
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Essentia Health Saint Joseph's Medical Center | Brainerd, Minnesota 56401 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Essentia Health Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
IU Health Methodist Hospital | Indianapolis, Indiana 46202 |
Toledo Clinic Cancer Centers-Bowling Green | Bowling Green, Ohio 43402 |
Toledo Clinic Cancer Centers-Maumee | Maumee, Ohio 43537-1839 |
Toledo Clinic Cancer Centers-Toledo | Toledo, Ohio 43623 |
PinnacleHealth Fox Chase Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17110 |
Cancer Center of Western Wisconsin | New Richmond, Wisconsin 54017 |