Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
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
5 other identifiers
interventional
211
2 countries
170
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Longer than P75 for phase_2
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedResults Posted
Study results publicly available
October 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2017
CompletedFebruary 26, 2018
February 1, 2018
4.5 years
May 7, 2010
April 18, 2016
February 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Undetectable PSA Rate
Undetectable PSA rate (\<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment
7 months
Secondary Outcomes (6)
Toxicity
Up to 28 weeks
Proportion of Patients Who do Not Achieve a Partial PSA Response
Up to 5 years
Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)
Up to 5 years
Correlation of microRNA Measures With 28-week PSA Response
Baseline to 28 weeks
Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts
Baseline
- +1 more secondary outcomes
Other Outcomes (3)
Change in Level of IGF-I, Free IGF-I and C-peptide
Baseline to 12 weeks
Change in Level of IGFBP2, IGFBP3 and Growth Hormone
Baseline to 12 weeks
Change in Level of Insulin
Baseline to 12 weeks
Study Arms (2)
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.
Arm II (androgen deprivation therapy)
ACTIVE COMPARATORPatients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.
Interventions
Given PO
Given IV
Given SC
Correlative studies
Given IM
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (170)
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group-Rogers
Rogers, Arkansas, 72758, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Tahoe Forest Cancer Center
Truckee, California, 96161, United States
San Luis Valley Regional Medical Center
Alamosa, Colorado, 81101, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
The Shaw Regional Cancer Center
Edwards, Colorado, 81632, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
Montrose Memorial Hospital
Montrose, Colorado, 81401, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
OnCare Hawaii-Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Oncare Hawaii Inc-Pali Momi
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Joseph Regional Medical Center
Lewiston, Idaho, 83501, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Hines Veterans Administration Hospital
Hines, Illinois, 60141, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Reid Health
Richmond, Indiana, 47374, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
University Health-Conway
Monroe, Louisiana, 71202, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, 71103, United States
Highland Clinic
Shreveport, Louisiana, 71105, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, 59102, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
University of Rochester
Rochester, New York, 14642, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45420, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Saint Charles Medical Center-Bend
Bend, Oregon, 97701, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
EvergreenHealth Medical Center
Kirkland, Washington, 98033, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
Virginia Mason CCOP
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Pacific Medical Center-First Hill
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Group Health Cooperative of Puget Sound Oncology Consortium
Seattle, Washington, 98112, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
United General Hospital
Sedro-Woolley, Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Rockwood Clinic
Spokane, Washington, 99220, United States
MultiCare Allenmore Hospital
Tacoma, Washington, 98405, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, 98405, United States
Saint Joseph Medical Center
Tacoma, Washington, 98405, United States
Multicare Health System
Tacoma, Washington, 98415, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Related Publications (1)
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.
PMID: 25847934DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evan Y. Yu, MD
- Organization
- Department of Medicine, Division of Oncology, University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Yu
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 10, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2015
Study Completion
August 23, 2017
Last Updated
February 26, 2018
Results First Posted
October 6, 2016
Record last verified: 2018-02