Prostate Cancer Clinical Trial

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

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.

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Full Description

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 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.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

108

Study ID:

NCT01251861

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 171 Locations for this study

See Locations Near You

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 Hospital
Boulder Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver Colorado, 80218, United States
SCL Health Saint Joseph Hospital
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
North Colorado Medical Center
Greeley Colorado, 80631, United States
Saint Anthony Hospital
Lakewood Colorado, 80228, United States
Littleton Adventist Hospital
Littleton Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Longmont United Hospital
Longmont Colorado, 80501, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Parker Adventist Hospital
Parker Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge Colorado, 80033, 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 District of Columbia, 20016, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, 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
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
Bromenn Regional 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 Cancer Treatment Center
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
Memorial Medical Center
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 PC - Ames
Ames Iowa, 50010, United States
Medical Oncology and Hematology Associates-West Des Moines
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
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Mission Cancer and Blood - Laurel
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
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Beaumont Hospital - Dearborn
Dearborn Michigan, 48124, United States
Ascension 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
Borgess Medical Center
Kalamazoo Michigan, 49048, United States
Sparrow Hospital
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
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Lake Huron Medical Center
Port Huron Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Lakeland Medical Center Saint Joseph
Saint Joseph Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
Saint John Macomb-Oakland 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, 89169, 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, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Hematology Oncology Associates
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
Saint Vincent Mercy Medical Center
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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

108

Study ID:

NCT01251861

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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