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ACTIVE NOT RECRUITING

NCT01251861

PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2010-12-23

Completion Date

2026-03-18

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Recurrent Prostate Carcinoma Stage I Prostate Cancer AJCC v7 Stage IIA Prostate Cancer AJCC v7 Stage IIB Prostate Cancer AJCC v7 Stage III Prostate Cancer AJCC v7

Interventions

DRUG

Akt Inhibitor MK2206

Given PO

DRUG

Bicalutamide

Given PO

OTHER

Clinical Observation

Undergo clinical observation

OTHER

Laboratory Biomarker Analysis

Correlative studies

Inclusion Criteria: * 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 * 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)

Locations (198)

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Rose Medical Center

Denver, Colorado, United States

Western States Cancer Research NCORP

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

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

Savannah, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Trinity Medical Center

Moline, Illinois, United States

Carle BroMenn Medical Center

Normal, Illinois, United States

Carle Cancer Institute Normal

Normal, Illinois, United States

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Proctor Hospital

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois Valley Hospital

Peru, Illinois, United States

Perry Memorial Hospital

Princeton, Illinois, United States

Swedish American Hospital

Rockford, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Richard L. Roudebush Veterans Affairs Medical Center

Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

IU Health Central Indiana Cancer Centers-East

Indianapolis, Indiana, United States

Community Howard Regional Health

Kokomo, Indiana, United States

IU Health La Porte Hospital

La Porte, Indiana, United States

Horizon Oncology Research LLC

Lafayette, Indiana, United States

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

South Bend Clinic

South Bend, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

McFarland Clinic - Ames

Ames, Iowa, United States

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

Clive, Iowa, United States

Iowa Methodist Medical Center