AzTrials
AzTrials

Recurrent Prostate CarcinomaPhase 2NCT01251861

Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer

A Phase 2 study testing Akt Inhibitor MK2206, Bicalutamide and Clinical Observation in people with Recurrent Prostate Carcinoma and Stage I Prostate Cancer AJCC v7, run by National Cancer Institute (NCI) at 198 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Akt Inhibitor MK2206, Bicalutamide and Clinical Observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
198 sitesin 2 countries
Study dates
17 Mar 2011to 26 May 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • PSA2 must be higher than PSA1, obtained at least 2 weeks after PSA1 and within 6 months or less from randomization
  • PSA3 must be higher than PSA2 and obtained at least 2 weeks after PSA2
  • Baseline PSA must have reached a minimum of 2 ng/mL but be no greater than 50 ng/mL and equal or higher than PSA3; PSA3 may be used as baseline PSA if obtained within 1 week of randomization
  • Patient's PSA doubling time (PSADT) must be less than 12 months
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Granulocytes >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Serum creatinine within normal institutional limits or creatinine clearance >= 50 ml/min for patients with creatinine levels above institutional normal
  • Serum total bilirubin =< 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase (ALP) =< 2.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x institutional upper limit of normal
  • Human immunodeficiency virus (HIV)-positive patients are excluded from this study
  • Patient cannot receive concurrent therapeutic administration of anticoagulant therapy; low dosage aspirin =< 325 mg per day is allowed
  • Patients with impaired cardiac function including any one of the following will be excluded from entry on study:
  • Baseline corrected QT interval (QTc) > 450 msec (male) (patients with QTc 450-480 msec will be allowed to participate in this trial if they do not have any of the other cardiac conditions mentioned in this section)
  • Patients with congenital long QT syndrome
  • History of sustained ventricular tachycardia
  • Any history of ventricular fibrillation or torsades de pointes
  • Concomitant use of drugs with a risk of causing torsades de pointes
  • Bradycardia defined as heart rate < 50 beats per minute; patients with a pacemaker and heart rate >= 50 beats per minute are eligible
  • Myocardial infarction or unstable angina within 6 months of study entry
  • Congestive heart failure (New York Heart Association class III or IV)
  • Right bundle branch block and left anterior hemi-block (bifascicular block)
  • Patient must not have gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
  • Patient may not be receiving any other investigational agents or receiving concurrent anticancer therapy (chemotherapy, immunotherapy, radiation therapy, surgery for cancer, or experimental medications) at time of randomization
  • Patient may not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or bicalutamide
  • Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with diabetes or at risk for hyperglycemia MUST not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial
  • Patients receiving any medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible
  • Patient must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:
  • Basal cell or squamous cell carcinoma of the skin OR
  • Prior malignancy has been adequately treated and patient has been continuously disease free for >= 2 years
  • Patient must agree to use barrier contraception during and for 3 months after discontinuation of study treatment; if patient impregnates a woman while on treatment or within 3 months of discontinuing treatment, he should inform his treating physician immediately
  • Patients must discontinue use of enzyme-inducing anti-epileptic drugs (EIAEDs) >= 14 days prior to study enrollment; the investigator may prescribe non-EIAEDs; patients who must begin EIAED therapy while on study will be allowed to remain
  • Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), St John's Wort, ketoconazole, dexamethasone, the dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice within two weeks of randomization and during the course of therapy
  • Patients may have received targeted agents (angiogenesis inhibitors, epidermal growth factor receptor [EGFR] inhibitors, mammalian target of rapamycin [mTOR] inhibitors, phosphatidylinositol 3 kinase [PI3K] inhibitors, etc.), however patients must have discontinued treatment with the targeted agent(s) at least 4 weeks prior to enrollment; if the patient stopped targeted agent(s) due to unresolved or persistent grade 3 or 4 toxicity, patient cannot be enrolled onto the study regardless of the length of time since discontinuation of treatment with targeted agent(s)

Who cannot join

None listed.

Trial locations and contacts

198 sites in 2 countries.

198 sites in 2 countries

United States192 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Hematology Oncology Associates

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Butler Memorial Hospital

    Butler, Pennsylvania, 16001

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western States Cancer Research NCORP

    Denver, Colorado, 80222

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Eureka Hospital

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Mason District Hospital

    Havana, Illinois, 62644

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • IU Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Richard L. Roudebush Veterans Affairs Medical Center

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • IU Health Central Indiana Cancer Centers-East

    Indianapolis, Indiana, 46219

  • Allegiance Health

    Jackson, Michigan, 49201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Horizon Oncology Research LLC

    Lafayette, Indiana, 47905

  • CommonSpirit Saint Anthony Hospital Cancer Center

    Lakewood, Colorado, 80228

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada, 89120

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Trinity Medical Center

    Moline, Illinois, 61265

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Mount Sinai Union Square

    New York, New York, 10003

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers-Oregon

    Oregon, Ohio, 43616

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • AdventHealth Parker

    Parker, Colorado, 80138

  • OSF Saint Francis Radiation Oncology at Pekin

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Swedish American Hospital

    Rockford, Illinois, 61104

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • HSHS Saint Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51102

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Trinity's Tony Teramana Cancer Center

    Steubenville, Ohio, 43952

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

  • Mercy Health - Saint Vincent Hospital

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Mercy Health - Saint Anne Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Henry Ford Health Warren Hospital

    Warren, Michigan, 48093

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Intermountain Health Lutheran Hospital

    Wheat Ridge, Colorado, 80401

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

Ireland6 sites

  • Cork University Hospital

    Cork

  • Tallaght University Hospital

    Dublin, Co Dublin, 24

  • Saint Vincent's University Hospital

    Dublin, Co Dublin, 4

  • Mater Misericordiae University Hospital

    Dublin, Co Dublin, 7

  • Mater Private Hospital

    Dublin, Co Dublin, 7

  • University College Hospital Galway

    Galway, Co Galway

Other trials in Ireland

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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 A: 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 B: 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.

Being tested
Akt Inhibitor MK2206, Bicalutamide, Clinical Observation, Laboratory Biomarker Analysis
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Akt Inhibitor MK2206Drug

    Also called MK 2206, MK-2206, MK-2206 FREE BASE, MK2206

    Given PO

  • BicalutamideDrug

    Also called Casodex, Cassotide, Cosudex, ICI 176,334

    Given PO

  • Clinical ObservationOther

    Also called observation

    Undergo clinical observation

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01251861
Study groupRoleWhat they receive
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.
Receives: Drug: Bicalutamide; Other: Clinical Observation; Other: Laboratory Biomarker Analysis
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.
Receives: Drug: Akt Inhibitor MK2206; Drug: Bicalutamide; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 44 weeks

Secondary outcomes (10)

  1. Proportion of Patients With PSA Decline > 85% at 44 Weeks

    Proportion of patients with PSA decline > 85% at 44 weeks from baseline, defined as number of patients with PSA decline > 85% at 44 weeks from baseline divided by number of patients randomized.

    Measured: 44 weeks

  2. Proportion of Patients With PSA Response

    PSA complete response (CR) is defined as a PSA <0.2 ng/mL confirmed on two consecutive additional determinations taken at least 4 weeks apart. PSA partial response (PR) is defined as a reduction in PSA ≥ 50% from baseline without evidence of progression (confirmed on two consecutive additional determinations taken at least 4 weeks apart). Either CR or PR is considered as a PSA response.

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

  3. Time to PSA Progression

    Time to PSA progression was defined as the time from randomization to PSA progression or date of last disease assessment showing progression-free. Development of clinical progression is also considered as an event.

    • For patients (pts) who achieved a ≥ 50% decline in PSA (confirmed on two consecutive determinations taken at least 4 weeks apart), progression is defined as an increase in PSA by 50% above baseline or nadir, whichever is lowest, confirmed by a 2nd PSA rise at least two weeks later. The PSA rise must be >= 5 ng/mL.
    • For pts with an undetectable PSA nadir (< 0.2 ng/mL confirmed on two consecutive determinations taken at least 4 weeks apart), progression is defined as PSA ≥ 0.2 ng/mL confirmed by a 2nd PSA rise at least 2 weeks later.
    • For pts whose PSA has not decreased by 50%, progression is defined as an increase in PSA of ≥ 50% of baseline or nadir PSA, whichever is lowest, confirmed by a repeat PSA at least 2 weeks later. The PSA must have risen by >= 5 ng/mL

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

  4. Time to PSA Nadir

    Time to PSA nadir was defined as the time from randomization to the date that PSA nadir, the lowest PSA value achieved after randomization, was documented. This analysis was performed among patients whose PSA level decreased after randomization compared to baseline.

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

  5. Duration of PSA Response

    Duration of PSA response was defined as the time from the date PSA criteria were met for complete response (CR) or partial response (PR), whichever status was recorded first, to the date of PSA progression. Patients without documented PSA progression were censored at the date of last disease assessment. Duration of PSA response is analyzed among responders (PSA CR or PR).

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

  6. PSA Slope Prior to Randomization

    PSA slopes were assessed by multiple PSA values prior to randomization. Linear regression was used to calculate PSA slope using natural log-transformed PSA values on the time of PSA measurements for each patient.

    Measured: Baseline (pre-randomization)

  7. PSA Slope After Randomization and Before Starting Bicalutamide

    PSA slopes were assessed by multiple PSA values from randomization to starting bicalutamide treatment. Linear regression was used to calculate PSA slope using natural log-transformed PSA values on the time of PSA measurements for each patient.

    Measured: After randomization and prior to starting bicalutamide

  8. PSA Slope After Starting Bicalutamide Treatment

    PSA slopes were assessed by multiple PSA values after starting bicalutamide treatment. Linear regression was used to calculate PSA slope using natural log-transformed PSA values on the time of PSA measurements for each patient.

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

  9. The Association Between Gleason Score and PSA Response

    The association between PSA response (responder vs non-responder) and Gleason score (<7, 7 vs. >7) was evaluated by logistic regression with adjustment for treatment assignment.

    Based on the biopsy sample, a Gleason grade is assigned to the most predominant pattern in the biopsy and a second Gleason grade is assigned to the second most predominant pattern. The two grades will then be added together to determine the Gleason score. Gleason scores range from 2-10. The higher the Gleason score, the more aggressive the cancer is likely to be.

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

  10. The Association Between Prior Hormonal Therapy and PSA Response

    The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.

    Measured: Assessed every 3 months for 2 years, every 6 months for 3 years, and then annually up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2010 (estimated)
  2. Study start17 Mar 2011
  3. Primary completion17 Jul 2018
  4. Study completion26 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251861
Sponsor's protocol ID
NCI-2011-02648
Other IDs
NCI-2011-02648, ECOG-E2809, CDR0000689613, 11-00834, E2809, E2809, E2809, U10CA180820
Status last verified
May 2026
First submitted
1 Dec 2010
Last updated
25 Jun 2026
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41609418

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Akt Inhibitor MK2206, Bicalutamide and Clinical Observation in people with Recurrent Prostate Carcinoma and Stage I Prostate Cancer AJCC v7, run by National Cancer Institute (NCI) at 198 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 51 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks (time frame: 44 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251861, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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