Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

NCT ID: NCT01120236

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-08-23

Brief Summary

This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective when given with or without cixutumumab in treating prostate cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the undetectable prostate-specific antigen (PSA) rate (PSA < 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment between those randomized to a luteinizing hormone-releasing hormone (LHRH) agonist and bicalutamide and those randomized to a LHRH agonist, bicalutamide and IMC-A12 (cixutumumab).

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of the combination of IMC-A12 with a LHRH agonist and bicalutamide.

II. To compare the proportion of men who do not achieve a PSA of < 4 ng/mL between the two groups.

III. To assess the accuracy of the prognostic model of undetectable PSA that was developed from Southwest Oncology Group (SWOG)-9346 using current trial data from each arm.

IV. To assess serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: insulin-like growth factor [IGF]-I, free IGF-I, IGF-II, IGF binding protein [IGFBP]2, IGFBP3, growth hormone, insulin and C-peptide) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy.

V. To determine baseline pre-treatment circulating tumor cell (CTC) quantities and response to therapy (for those patients with detectable CTC levels >= 1) twelve weeks later.

VI. In the same subset of patients where CTC levels are obtained, determine baseline serum levels of micro-ribonucleic acids (RNAs) to include but not limited to microRNA (mi)-141 both before initiation of androgen deprivation therapy and twelve weeks after combined therapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive androgen deprivation therapy comprising bicalutamide orally (PO) once daily (QD) on days 1-28 and either goserelin acetate subcutaneously (SC) or leuprolide acetate intramuscularly (IM) every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab intravenously (IV) over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.

Conditions

Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (androgen deprivation and cixutumumab)

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Bicalutamide

Intervention Type: DRUG

Given PO

Cixutumumab

Intervention Type: BIOLOGICAL

Given IV

Goserelin Acetate

Intervention Type: DRUG

Given SC

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Leuprolide Acetate

Intervention Type: DRUG

Given IM

Pharmacological Study

Intervention Type: OTHER

Correlative studies

Arm II (androgen deprivation therapy)

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Group Type: ACTIVE_COMPARATOR

Bicalutamide

Intervention Type: DRUG

Given PO

Goserelin Acetate

Intervention Type: DRUG

Given SC

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Leuprolide Acetate

Intervention Type: DRUG

Given IM

Pharmacological Study

Intervention Type: OTHER

Correlative studies

Interventions

Bicalutamide

Given PO

Intervention Type: DRUG

Cixutumumab

Given IV

Intervention Type: BIOLOGICAL

Goserelin Acetate

Given SC

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Leuprolide Acetate

Given IM

Intervention Type: DRUG

Pharmacological Study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Casodex; Cosudex; ICI 176,334; ICI 176334; Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12; IMC-A12; ZDX; Zoladex; A-43818; Abbott 43818; Abbott-43818; Carcinil; Depo-Eligard; Eligard; Enanton; Enantone; Enantone-Gyn; Ginecrin; LEUP; Leuplin; Leuprorelin Acetate; Lucrin; Lucrin Depot; Lupron; Lupron Depot; Lupron Depot-3 Month; Lupron Depot-4 Month; Lupron Depot-Ped; Procren; Procrin; Prostap; TAP-144; Trenantone; Uno-Enantone; Viadur

Eligibility Criteria

Inclusion Criteria

• All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate; note: If there is no formal biopsy report documenting the diagnosis of prostate cancer, the patient can be allowed on trial if the PSA level is at least 20, and there are at least three definitive metastatic lesions seen on scan; all patients must have had metastatic (M1) disease as evidenced by soft tissue and/or bony metastases prior to androgen deprivation therapy initiation; patients must have at least one of the following at the time they started androgen deprivation therapy:

• Visceral disease (liver, lung, or other viscera)
• Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
• Lymph node disease not considered to be encompassed within a single radiotherapy port (e.g., above the aortic bifurcation, etc.)
• Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic computed tomography [CT]) within 28 days prior to registration; non-measurable disease must also be assessed (e.g., bone scan) in all patients within 56 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
• Patients must have a PSA >= 5 ng/mL obtained within 90 days prior to initiation of androgen deprivation therapy
• Patients with known brain metastases are not eligible; brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms, but if brain imaging studies are performed, they must be negative for disease
• Patient must have had no more than 30 days of prior medical castration for metastatic prostate cancer (prior androgen deprivation therapy is allowed if it was received with curative intent in the neoadjuvant, concurrent, and/or adjuvant fashion and at least 2 years have elapsed since completion of androgen deprivation therapy); the start date of medical castration is considered the day the patient first received an injection of a LHRH agonist, not an oral antiandrogen; if the method of castration is luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonists and add bicalutamide for combined androgen deprivation therapy (ADT) during protocol treatment; the 30 day window begins from the date of receiving the LHRH agonist, not the oral antiandrogen; if the patient was on a different antiandrogen (e.g. flutamide), the patient must be willing to switch over to bicalutamide; patients must not have received bilateral orchiectomy; patients must not have received or be planning to receive LHRH antagonists (i.e., Degarelix); however, if the patient was initiated on a LHRH antagonist within the 30 day window and is willing to switch to a LHRH agonist with bicalutamide, he may enroll on the late induction group
• Patients who have not already started androgen deprivation therapy must be offered the opportunity to participate in the translational medicine studies; once a patient has started any form of antiandrogen (i.e., either bicalutamide or LHRH agonist), he is not eligible for any translational medicine studies
• Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; patients must not have received any prior treatment with agents that directly inhibit IGF or IGFRs
• Patients must not have received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionuclide therapy within 28 days prior to registration
• Patients may have received prior radiation therapy or biologic therapy (e.g. vaccines, immunotherapy, anti-sense, small molecules, monoclonal antibodies); however, at least 28 days must have elapsed since completion of therapy and patient must have recovered from all side effects
• Patients may have received prior surgery; for all major surgeries, at least 28 days must have elapsed since completion and patient must have recovered from all side effects
• Leukocytes >= 3,000 mcL
• Absolute neutrophil count (ANC) >= 1,500 mcL
• Hemoglobin >= 9 g/dL
• Platelets >= 100,000/mcL
• Bilirubin =< 1.5 times the institutional upper limit of normal (ULN) (unless documented Gilbert's disease)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 times the institutional ULN, or =< 5 times the institutional ULN if liver metastases are present
• Creatinine =< 2.0 x the institutional ULN or calculated creatinine clearance >= 40 mL/min
• International normalized ratio (INR) =< 1.5
• Partial thromboplastin time (PTT) no more than 5 seconds above the institutional ULN
• Patients receiving prophylactic low dose coumadin or low molecular weight heparin are eligible as long as they meet these coagulation criteria; patients requiring full-dose (therapeutic) anticoagulation are eligible provided that they have been on a stable dose of anticoagulation and the coagulation parameters are stable within the therapeutic range (e.g., INR 2-3 for patients on therapeutic warfarin)
• Patients must have a hemoglobin A1c (HgA1c) =< 7% AND fasting glucose of < 160 mg/dL or below the institutional ULN within 14 days prior to registration; patients with diabetes mellitus who meet this criterion must be on a stable dietary or therapeutic regimen for this condition
• Patients must not have a history of symptomatic congestive heart failure or a known ejection fraction (left ventricular ejection fraction [LVEF]) that is >= 10% below the lower limit of normal (LLN); if left ventricular (LV) dysfunction is suspected, but not confirmed by review of past medical history, a multi gated acquisition scan (MUGA) or echocardiogram must be obtained within 90 days prior to registration
• Patient must not have a history of allergic reaction attributed to compounds of similar chemical or biologic composition to IMC-A12; patients must not have received prior chimerized or murine monoclonal antibody therapy
• Patients must have a Zubrod performance status of 0 - 2; Zubrod performance status 3 will be allowed if from bone pain only
• Patients with human immunodeficiency virus (HIV) positivity requiring antiretroviral therapy are not eligible for this study
• Patients must have no plans to receive concurrent chemotherapy, hormonal therapy (other than the LHRH agonist and oral anti-androgen), radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment; concurrent bone targeting agents that do not have effect on PSA (i.e. denosumab or zoledronic acid) are allowed
• Patients must have no plans to receive concurrent five-alpha reductase inhibitors (e.g. finasteride and dutasteride), ketoconazole, diethylstilbestrol/DES, or other estrogen-based therapy while on this protocol treatment
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
• Men of reproductive potential must have agreed to use an effective contraceptive method while receiving treatment on this study and for at least three months after protocol treatment ends
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Yu

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Highlands Oncology Group-Rogers

Rogers, Arkansas, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Valley Medical Oncology Consultants

Pleasanton, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Tahoe Forest Cancer Center

Truckee, California, United States

San Luis Valley Regional Medical Center

Alamosa, Colorado, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, United States

The Shaw Regional Cancer Center

Edwards, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Montrose Memorial Hospital

Montrose, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Oncare Hawaii Inc-POB II

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Kuakini Medical Center

Honolulu, Hawaii, United States

OnCare Hawaii-Kuakini

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Castle Medical Center

Kailua, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Oncare Hawaii Inc-Pali Momi

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Joseph Regional Medical Center

Lewiston, Idaho, United States

Saint Anthony's Health

Alton, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Hines Veterans Administration Hospital

Hines, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, United States

Reid Health

Richmond, Indiana, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence

Independence, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates In Womens Health

Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Via Christi Regional Medical Center

Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

University Health-Conway

Monroe, Louisiana, United States

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, United States

Highland Clinic

Shreveport, Louisiana, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, United States

Beaumont Hospital-Dearborn

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Saint John Hospital and Medical Center

Detroit, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, United States

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

Sparrow Hospital

Lansing, Michigan, United States

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Mercy Health Mercy Campus

Muskegon, Michigan, United States

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

Saint Joseph Mercy Port Huron

Port Huron, Michigan, United States

Spectrum Health Reed City Hospital

Reed City, Michigan, United States

Saint Mary's of Michigan

Saginaw, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Metro Health Hospital

Wyoming, Michigan, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Montana Cancer Consortium NCORP

Billings, Montana, United States

Saint Vincent Healthcare

Billings, Montana, United States

Frontier Cancer Center and Blood Institute-Billings

Billings, Montana, United States

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Saint Peter's Community Hospital

Helena, Montana, United States

Glacier Oncology PLLC

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Montana Cancer Specialists

Missoula, Montana, United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

University of Rochester

Rochester, New York, United States

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Iredell Memorial Hospital

Statesville, North Carolina, United States

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, United States

Grandview Hospital

Dayton, Ohio, United States

Good Samaritan Hospital - Dayton

Dayton, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Samaritan North Health Center

Dayton, Ohio, United States

Dayton NCI Community Oncology Research Program

Dayton, Ohio, United States

Blanchard Valley Hospital

Findlay, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Wayne Hospital

Greenville, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

Clinton Memorial Hospital

Wilmington, Ohio, United States

Wright-Patterson Medical Center

Wright-Patterson Air Force Base, Ohio, United States

Greene Memorial Hospital

Xenia, Ohio, United States

Saint Charles Medical Center-Bend

Bend, Oregon, United States

AnMed Health Cancer Center

Anderson, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Danville Regional Medical Center

Danville, Virginia, United States

Cancer Care Center at Island Hospital

Anacortes, Washington, United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, United States

Highline Medical Center-Main Campus

Burien, Washington, United States

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Providence Regional Cancer Partnership

Everett, Washington, United States

Saint Francis Hospital

Federal Way, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

EvergreenHealth Medical Center

Kirkland, Washington, United States

Saint Clare Hospital

Lakewood, Washington, United States

Skagit Valley Hospital

Mount Vernon, Washington, United States

Providence - Saint Peter Hospital

Olympia, Washington, United States

Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, United States

MultiCare Good Samaritan Hospital

Puyallup, Washington, United States

Virginia Mason CCOP

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical PLLC

Seattle, Washington, United States

Pacific Medical Center-First Hill

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Group Health Cooperative of Puget Sound Oncology Consortium

Seattle, Washington, United States

Group Health Cooperative-Seattle

Seattle, Washington, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

The Polyclinic

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

United General Hospital

Sedro-Woolley, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Evergreen Hematology and Oncology PS

Spokane, Washington, United States

Rockwood Clinic

Spokane, Washington, United States

MultiCare Allenmore Hospital

Tacoma, Washington, United States

Northwest NCI Community Oncology Research Program

Tacoma, Washington, United States

Saint Joseph Medical Center

Tacoma, Washington, United States

Multicare Health System

Tacoma, Washington, United States

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, United States

Rocky Mountain Oncology

Casper, Wyoming, United States

Welch Cancer Center

Sheridan, Wyoming, United States

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

Yu EY, Li H, Higano CS, Agarwal N, Pal SK, Alva A, Heath EI, Lam ET, Gupta S, Lilly MB, Inoue Y, Chi KN, Vogelzang NJ, Quinn DI, Cheng HH, Plymate SR, Hussain M, Tangen CM, Thompson IM Jr. SWOG S0925: A Randomized Phase II Study of Androgen Deprivation Combined With Cixutumumab Versus Androgen Deprivation Alone in Patients With New Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2015 May 10;33(14):1601-8. doi: 10.1200/JCO.2014.59.4127. Epub 2015 Apr 6.

Reference Type: DERIVED

PMID: 25847934 (View on PubMed)

Other Identifiers

NCI-2011-02003

Identifier Type: REGISTRY

Identifier Source: secondary_id

SWOG-S0925

Identifier Type: -

Identifier Source: secondary_id

CDR0000663832

Identifier Type: -

Identifier Source: secondary_id

S0925

Identifier Type: OTHER

Identifier Source: secondary_id

S0925

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2011-02003

Identifier Type: -

Identifier Source: org_study_id