Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
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
7 other identifiers
interventional
108
2 countries
198
Brief Summary
This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2010
Longer than P75 for phase_2
198 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedStudy Start
First participant enrolled
December 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2018
CompletedResults Posted
Study results publicly available
December 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedApril 29, 2026
December 1, 2025
7.6 years
December 1, 2010
September 25, 2019
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks
The proportion of patients with undetectable PSA level (\< 0.2 ng/mL) at 44 weeks, defined as number of patients with undetectable PSA level at 44 weeks divided by number of patients randomized.
44 weeks
Secondary Outcomes (10)
Proportion of Patients With PSA Decline > 85% at 44 Weeks
44 weeks
Proportion of Patients With PSA Response
Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years
Time to PSA Progression
Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years
Time to PSA Nadir
Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years
Duration of PSA Response
Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years
- +5 more secondary outcomes
Other Outcomes (1)
Samples of the Primary Tumor Specimen Will be Retrieved for Banking and Future Analysis of the Molecular Profile of the Primary PC Tissues With Emphasis on the AR and Akt Upstream and Downstream Signaling Pathways.
Baseline
Study Arms (2)
Arm A (observation and bicalutamide)
ACTIVE COMPARATORPatients undergo observation on weeks 1-12. Patients then receive bicalutamide PO 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 B (Akt inhibitor MK2206 and bicalutamide)
EXPERIMENTALPatients 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 Akt inhibitor MK2206 and bicalutamide until week 72 in the absence of disease progression or unacceptable toxicity.
Interventions
Correlative studies
Given PO
Given PO
Undergo clinical observation
Eligibility Criteria
You may qualify if:
- Patient must have histologically confirmed diagnosis of prostate cancer
- Patient must have had previous treatment with definitive surgery or radiation therapy or cryoablation
- Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 4 weeks prior to randomization if the intent was for cure; prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
- Patient must have no evidence of metastatic disease on physical exam, computed tomography (CT) abdomen/pelvis (or magnetic resonance imaging \[MRI\]), chest x-ray (or CT chest) and bone scan within 8 weeks prior to randomization
- Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSA doubling time (PSADT) were documented after the testosterone level was \> 150 ng/dL
- Patient may not have had therapy modulating testosterone levels (such as luteinizing-hormone, releasing-hormone agonists/antagonists and antiandrogens) within 1 year prior to randomization, unless it was in the neoadjuvant and/or adjuvant setting; agents such as 5 alpha reductase inhibitors, ketoconazole, abiraterone, systemic steroids, or herbal supplements known to decrease PSA levels including any dose of megestrol acetate, finasteride (e.g., Saw Palmetto and PC-SPES, African pygeum extract, lycopene, alanine, glutamic acid and glycine, beta-sitosterol, lycopene, nettle root extract, quercitin, Belizian Man Vine extract, mulra puama extract and epimedium extract campesterol, beta-sitosterol, stigmasterol, sitostanol and brassicasterol) are not permitted at any time during the period that the PSA values are being collected
- Patient must have hormone-sensitive prostate cancer as evident by a serum total testosterone level \> 150 ng/dL within 12 weeks prior to randomization
- Patient must have evidence of biochemical failure after primary therapy and subsequent progression
- Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy
- For radical prostatectomy the threshold for this study is PSA \>= 0.4 ng/mL
- For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 Radiation Therapy Oncology Group \[RTOG\]-American Society for Radiation Oncology \[ASTRO\] Consensus definition)
- PSA progression requires a PSA rise above the threshold (PSA1) measured at any time point since the threshold was reached
- The PSADT must be \< 12 months; requires two consecutive PSA rises (PSA2 and PSA3) above the PSA1; PSA2 and PSA3 must be obtained within 6 months of study entry; all baseline PSAs should be obtained, preferably, at the same reference lab
- PSADT calculation needs 3 PSA values:
- PSA1 is any PSA value that is equal or greater than the threshold PSA (0.4 ng/mL for radical prostatectomy or 2 ng/mL above the nadir for primary radiation therapy) indicating biochemical relapse
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (198)
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, 60521, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Carle BroMenn Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, 46219, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Horizon Oncology Research LLC
Lafayette, Indiana, 47905, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89120, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Hematology Oncology Associates
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011, United States
Mount Sinai Union Square
New York, New York, 10003, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Fisher-Titus Medical Center
Norwalk, Ohio, 44857, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, 43952, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Butler Memorial Hospital
Butler, Pennsylvania, 16001, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Tallaght University Hospital
Dublin, Co Dublin, 24, Ireland
Saint Vincent's University Hospital
Dublin, Co Dublin, 4, Ireland
Mater Misericordiae University Hospital
Dublin, Co Dublin, 7, Ireland
Mater Private Hospital
Dublin, Co Dublin, 7, Ireland
University College Hospital Galway
Galway, Co Galway, Ireland
Cork University Hospital
Cork, Ireland
Related Publications (1)
Ferrari AC, Chen YH, Rodriguez R, Hudes GR, Antonarakis ES, Hahn NM, Ma H, Plimack ER, Mayer T, Carthon BC, Liu G, Carducci MA, DiPaola R. Phase II Randomized Study of MK-2206 and Bicalutamide in Prostate Cancer Patients With Rising PSA After Primary Therapy (ECOG-ACRIN E2809). Prostate. 2026 May;86(6):697-709. doi: 10.1002/pros.70125. Epub 2026 Jan 29.
PMID: 41609418DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Anna C Ferrari
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 2, 2010
Study Start
December 23, 2010
Primary Completion
July 17, 2018
Study Completion (Estimated)
March 31, 2027
Last Updated
April 29, 2026
Results First Posted
December 5, 2019
Record last verified: 2025-12