AzTrials
AzTrials

Prostate AdenocarcinomaPhase 2NCT01120236

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

A Phase 2 study testing Bicalutamide, Cixutumumab and Goserelin Acetate in people with Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, run by National Cancer Institute (NCI) at 170 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 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Bicalutamide, Cixutumumab and Goserelin Acetate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
170 sitesin 2 countries
Study dates
Dec 2010to 23 Aug 2017
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

  • 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
Show all 34Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

170 sites in 2 countries.

170 sites in 2 countries

United States169 sites

  • Oncare Hawaii Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • San Luis Valley Regional Medical Center

    Alamosa, Colorado, 81101

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Medical Center-Bend

    Bend, Oregon, 97701

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • The Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hines Veterans Administration Hospital

    Hines, Illinois, 60141

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • OnCare Hawaii-Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Allegiance Health

    Jackson, Michigan, 49201

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • EvergreenHealth Medical Center

    Kirkland, Washington, 98033

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Joseph Regional Medical Center

    Lewiston, Idaho, 83501

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • University Health-Conway

    Monroe, Louisiana, 71202

  • Montrose Memorial Hospital

    Montrose, Colorado, 81401

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Providence - Saint Peter Hospital

    Olympia, Washington, 98506-5166

  • UF Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Reid Health

    Richmond, Indiana, 47374

  • University of Rochester

    Rochester, New York, 14642

  • Highlands Oncology Group-Rogers

    Rogers, Arkansas, 72758

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Pacific Medical Center-First Hill

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Cooperative of Puget Sound Oncology Consortium

    Seattle, Washington, 98112

  • Group Health Cooperative-Seattle

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • The Polyclinic

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology PS

    Spokane, Washington, 99218

  • Rockwood Clinic

    Spokane, Washington, 99220

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • MultiCare Allenmore Hospital

    Tacoma, Washington, 98405

  • Northwest NCI Community Oncology Research Program

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • Multicare Health System

    Tacoma, Washington, 98415

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Wright-Patterson Medical Center

    Wright-Patterson Air Force Base, Ohio, 45433-5529

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

Canada1 site

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Randomized Phase II Study of Androgen Deprivation Combined With IMC-A12 Versus Androgen Deprivation Alone for Patients With New Hormone Sensitive Metastatic Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
Bicalutamide, Cixutumumab, Goserelin Acetate, Laboratory Biomarker Analysis, Leuprolide Acetate
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • BicalutamideDrug

    Also called Casodex, Cosudex, ICI 176,334, ICI 176334

    Given PO

  • CixutumumabBiological

    Also called Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12, IMC-A12

    Given IV

  • Goserelin AcetateDrug

    Also called ZDX, Zoladex

    Given SC

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Leuprolide AcetateDrug

    Also called A-43818, Abbott 43818, Abbott-43818, Carcinil

    Given IM

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT01120236
Study groupRoleWhat they receive
Arm I (androgen deprivation and cixutumumab)ExperimentalPatients 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.
Receives: Drug: Bicalutamide; Biological: Cixutumumab; Drug: Goserelin Acetate; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Other: Pharmacological Study
Arm II (androgen deprivation therapy)Active comparatorPatients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Receives: Drug: Bicalutamide; Drug: Goserelin Acetate; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Other: Pharmacological Study

What is being measured

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

  1. Undetectable PSA Rate

    Undetectable PSA rate (<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment

    Measured: 7 months

Secondary outcomes (6)

  1. Toxicity

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to 28 weeks

  2. Proportion of Patients Who do Not Achieve a Partial PSA Response

    A partial PSA response is considered <= 4 ng/mL

    Measured: Up to 5 years

  3. Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)

    The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.

    Measured: Up to 5 years

  4. Correlation of microRNA Measures With 28-week PSA Response

    The Friedman test will be used to evaluate correlations between microRNA measures (CT) and 28-week PSA response.

    Measured: Baseline to 28 weeks

  5. Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts

    The Friedman test will be used to evaluate correlations between microRNA measures (CT) and Baseline CTCs.

    Measured: Baseline

  6. Change in Level of CTCs

    Will be correlated with 28-week PSA response.

    Measured: Baseline to 28 weeks

Timeline

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

  1. First posted10 May 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJun 2015
  4. Study completion23 Aug 2017

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
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120236
Sponsor's protocol ID
NCI-2011-02003
Other IDs
NCI-2011-02003, SWOG-S0925, CDR0000663832, S0925, S0925, U10CA032102
Status last verified
Feb 2018
First submitted
7 May 2010
Last updated
26 Feb 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25847934

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bicalutamide, Cixutumumab and Goserelin Acetate in people with Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, run by National Cancer Institute (NCI) at 170 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 34 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 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Canada. 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 6 Oct 2016). 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?

Undetectable PSA Rate (time frame: 7 months). 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 NCT01120236, 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 26 Feb 2018.

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