Back to resultsAndrogen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer (CHAARTED)
Primary Purpose
Metastatic Hormone-sensitive Prostate Cancer
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
androgen-deprivation therapy
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Hormone-sensitive Prostate Cancer focused on measuring metastatic hormone-sensitive prostate cancer, docetaxel
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed prostate cancer Metastatic disease On androgen-deprivation therapy for < 120 days Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 PS 2 eligible only if decline in PS is due to metastatic prostate cancer Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤ 2.5 times ULN Creatinine clearance ≥ 30 mL/min Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation) Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation) Fertile patients must use effective contraception At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true: Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following: PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy Therapy lasted no more than 24 months Last depot injection must have expired by the 24-month mark Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial Concurrent participation in nontherapeutic trials allowed Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy Exclusion Criteria: Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair Peripheral neuropathy > grade 1 History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 Active cardiac disease, including the following: Active angina Symptomatic congestive heart failure Myocardial infarction within the past 6 months Prior chemotherapy in adjuvant or neoadjuvant setting Prior hormone therapy in the metastatic setting Concurrent 5-alpha reductase inhibitors Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202
Sites / Locations
- Providence Cancer Center
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Mayo Clinic Hospital
- Mayo Clinic Scottsdale
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- California Cancer Care, Incorporated - Greenbrae
- USC/Norris Comprehensive Cancer Center and Hospital
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Mather Veteran Affairs Medical Center
- Mercy Cancer Center at Mercy Medical Center
- Memorial Medical Center
- Sutter Health - Western Division Cancer Research Group
- University of California Davis Cancer Center
- Saint Helena Hospital
- California Pacific Medical Center - California Campus
- Sutter Pacific Medical Foundation
- Tahoe Forest Cancer Center
- Sutter Solano Medical Center
- University of Colorado Cancer Center at UC Health Sciences Center
- Veterans Affairs Medical Center - Denver
- Shaw Regional Cancer Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- Montrose Memorial Hospital Cancer Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Yale Cancer Center
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- George Washington University Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- University of Florida Shands Cancer Center
- Mayo Clinic - Jacksonville
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Northeast Georgia Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Idaho Urologic Institute, PA
- Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute
- Mountain States Tumor Institute at St. Luke's
- Rush-Copley Cancer Care Center
- Illinois CancerCare - Bloomington
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Evanston Hospital
- St. Francis Hospital
- Galesburg Clinic, PC
- Illinois CancerCare - Cottage
- Illinois CancerCare - Havana
- Kellogg Cancer Care Center
- Veterans Affairs Medical Center - Hines
- Hinsdale Hematology Oncology Associates
- Joliet Oncology-Hematology Associates, Limited - West
- Provena St. Mary's Regional Cancer Center - Kankakee
- Illinois CancerCare - Kewanee Clinic
- La Grange Memorial Hospital
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Illinois CancerCare - Monmouth
- Good Samaritan Regional Health Center
- Hematology Oncology Consultants - Naperville
- Cancer Care and Hematology Specialists of Chicagoland - Niles
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Hematology Oncology Associates - Skokie
- Illinois CancerCare - Spring Valley
- Regional Cancer Center at Memorial Medical Center
- CCOP - Carle Cancer Center
- Elkhart Clinic, LLC
- Michiana Hematology-Oncology, PC - Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology
- Indiana University Melvin and Bren Simon Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- William N. Wishard Memorial Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- Michiana Hematology-Oncology, PC - South Bend
- Saint Joseph Regional Medical Center
- Michiana Hematology Oncology PC - Plymouth
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC - La Porte
- Medical Oncology and Hematology Associates - West Des Moines
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Veterans Affairs Medical Center - Iowa City
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Hays Medical Center
- Hutchinson Hospital Corporation
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Mount Carmel Regional Cancer Center
- St. Francis Comprehensive Cancer Center
- Lucille P. Markey Cancer Center at University of Kentucky
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- DeCesaris Cancer Institute at Anne Arundel Medical Center
- Greenebaum Cancer Center at University of Maryland Medical Center
- Veterans Affairs Medical Center - Baltimore
- Greater Baltimore Medical Center Cancer Center
- St. Agnes Hospital Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
- Boston University Cancer Research Center
- Lahey Clinic Medical Center - Burlington
- Newton-Wellesley Hospital
- Jordan Hospital Club Cancer Center
- Commonwealth Hematology-Oncology, PC - Quincy
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Regional Cancer Center
- St. Mary Mercy Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Lakeside Cancer Specialists, PLLC
- St. John Macomb Hospital
- MeritCare Bemidji
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- New Ulm Medical Center
- Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Willmar Cancer Center at Rice Memorial Hospital
- Minnesota Oncology - Woodbury
- University of Mississippi Cancer Clinic
- Regional Cancer Center at Singing River Hospital
- Central Care Cancer Center at Carrie J. Babb Cancer Center
- Skaggs Cancer Center at Skaggs Regional Medical Center
- Saint Francis Medical Center
- Truman Medical Center - Hospital Hill
- Midwest Hematology Oncology Group, Incorporated
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- CCOP - Nevada Cancer Research Foundation
- Nevada Cancer Institute
- Veterans Affairs Medical Center - East Orange
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Cancer Institute of New Jersey at Hamilton
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Frederick R. and Betty M. Smith Cancer Treatment Center
- Overlook Hospital
- Kings County Hospital Center
- SUNY Downstate Medical Center
- Roswell Park Cancer Institute
- Tucker Center for Cancer Care at Orange Regional Medical Center
- NYU Cancer Institute at New York University Medical Center
- SUNY Upstate Medical University Hospital
- Dickstein Cancer Treatment Center at White Plains Hospital Center
- Wayne Memorial Hospital, Incorporated
- Pardee Memorial Hospital
- Kinston Medical Specialists
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- MeritCare Broadway
- CCOP - MeritCare Hospital
- Roger Maris Cancer Center at MeritCare Hospital
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Cleveland Clinic Beachwood Family Health and Surgery Center
- Aultman Cancer Center at Aultman Hospital
- Adena Regional Medical Center
- Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Zangmeister Center
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Cleveland Clinic Cancer Center
- Fairfield Medical Center
- St. Rita's Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Parma Community General Hospital
- Southern Ohio Medical Center Cancer Center
- North Coast Cancer Care, Incorporated
- Community Hospital of Springfield and Clark County
- Cleveland Clinic Foundation - Strongsville
- Mount Carmel St. Ann's Cancer Center
- Cleveland Clinic - Wooster
- Genesis - Good Samaritan Hospital
- Oklahoma University Cancer Institute
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Adams Cancer Center
- Cherry Tree Cancer Center
- Geisinger Hazleton Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- St. Joseph Medical Center
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Geisinger Medical Group - Scenery Park
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- York Cancer Center at Apple Hill Medical Center
- Avera Cancer Institute
- MBCCOP - Meharry Medical College - Nashville
- Veterans Affairs Medical Center - San Antonio (Murphy)
- University of Texas Health Science Center at San Antonio
- Cancer Therapy and Research Center
- University Hospital - San Antonio
- University of Virginia Cancer Center
- Lynchburg Hematology-Oncology Clinic
- Cascade Cancer Center at Evergreen Hospital Medical Center
- CCOP - Virginia Mason Research Center
- Virginia Mason Medical Center
- Pacific Medical Center
- West Virginia University Health Sciences Center - Charleston
- Langlade Memorial Hospital
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Gundersen Lutheran Center for Cancer and Blood
- Dean Medical Center - Madison
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Vince Lombardi Cancer Clinic - Marinette
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Medical College of Wisconsin Cancer Center
- Marshfield Clinic - Lakeland Center
- Green Bay Oncology, Limited - Oconto Falls
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- St. Nicholas Hospital
- Vince Lombardi Cancer Clinic - Sheboygan
- Marshfield Clinic at Saint Michael's Hospital
- Saint Michael's Hospital Cancer Center
- Green Bay Oncology, Limited - Sturgeon Bay
- Aurora Medical Center
- Vince Lombardi Cancer Clinic - Two Rivers
- Marshfield Clinic - Wausau Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Oncology Alliance, SC - Milwaukee - West
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Androgen-Deprivation Therapy and Docetaxel
Androgen-Deprivation Therapy alone
Arm Description
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Secondary Outcome Measures
Time to Clinical Progression
Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Proportion of Patients With PSA Complete Response (CR) at 6 Months
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Proportion of Patients With PSA Complete Response (CR) at 12 Months
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
QOL Change From Baseline to 3 Months
The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Full Information
NCT ID
NCT00309985
First Posted
March 29, 2006
Last Updated
June 20, 2023
Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00309985
Brief Title
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
Acronym
CHAARTED
Official Title
CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2006 (Actual)
Primary Completion Date
December 23, 2013 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
Detailed Description
OBJECTIVES:
Primary
Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer.
Secondary
Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone.
Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone.
Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone.
Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm.
Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone.
Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire.
Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival.
Tertiary
Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer.
Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes.
Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≥ 70 vs < 70), ECOG performance status (0-1 vs 2), combined androgen blockade for > 30 days (yes vs no), duration of prior adjuvant hormonal therapy (> 12 months vs ≤ 12 months), concurrent bisphosphonate use (yes vs no), and volume of disease (low vs high). Patients are randomized to 1 of 2 treatment arms.
Arm A (Androgen-Deprivation Therapy and Docetaxel): Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm B (Androgen-Deprivation Therapy alone): Patients receive androgen-deprivation therapy (as in arm A) alone.
Quality of life is assessed at baseline and at months 3, 6, 9 and 12.
After completion of study treatment, patients are followed up periodically for up to 10 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Hormone-sensitive Prostate Cancer
Keywords
metastatic hormone-sensitive prostate cancer, docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
790 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Androgen-Deprivation Therapy and Docetaxel
Arm Type
Experimental
Arm Description
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Arm Title
Androgen-Deprivation Therapy alone
Arm Type
Active Comparator
Arm Description
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.
Intervention Type
Drug
Intervention Name(s)
androgen-deprivation therapy
Intervention Description
LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere, RP 56976, NSC #628503
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Time Frame
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Secondary Outcome Measure Information:
Title
Time to Clinical Progression
Description
Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Title
Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
Description
Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Title
Proportion of Patients With PSA Complete Response (CR) at 6 Months
Description
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Time Frame
Assessed at 6 months
Title
Proportion of Patients With PSA Complete Response (CR) at 12 Months
Description
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
Time Frame
Assessed at 12 months
Title
QOL Change From Baseline to 3 Months
Description
The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Time Frame
Assessed at baseline and 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed prostate cancer
Metastatic disease
On androgen-deprivation therapy for < 120 days
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
PS 2 eligible only if decline in PS is due to metastatic prostate cancer
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ upper limit of normal (ULN)
Alanine aminotransferase (ALT) ≤ 2.5 times ULN
Creatinine clearance ≥ 30 mL/min
Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
Fertile patients must use effective contraception
At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:
Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:
PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy
PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy
Therapy lasted no more than 24 months
Last depot injection must have expired by the 24-month mark
Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare
More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
Concurrent participation in nontherapeutic trials allowed
Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy
Exclusion Criteria:
Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization
Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin
Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
Peripheral neuropathy > grade 1
History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Active cardiac disease, including the following:
Active angina
Symptomatic congestive heart failure
Myocardial infarction within the past 6 months
Prior chemotherapy in adjuvant or neoadjuvant setting
Prior hormone therapy in the metastatic setting
Concurrent 5-alpha reductase inhibitors
Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sweeney, MBBS
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Providence Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
City
Fairbanks
State/Province
Alaska
ZIP/Postal Code
99701
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Alta Bates Summit Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Peninsula Medical Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
California Cancer Care, Incorporated - Greenbrae
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Facility Name
Mather Veteran Affairs Medical Center
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Memorial Medical Center
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Sutter Health - Western Division Cancer Research Group
City
Novato
State/Province
California
ZIP/Postal Code
94945
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Saint Helena Hospital
City
Saint Helena
State/Province
California
ZIP/Postal Code
94574
Country
United States
Facility Name
California Pacific Medical Center - California Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Sutter Pacific Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Sutter Solano Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
University of Colorado Cancer Center at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Shaw Regional Cancer Center
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Front Range Cancer Specialists
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
Montrose Memorial Hospital Cancer Center
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Idaho Urologic Institute, PA
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Mountain States Tumor Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Illinois CancerCare - Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Hematology and Oncology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare - Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
St. Francis Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Cottage
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Kellogg Cancer Care Center
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Provena St. Mary's Regional Cancer Center - Kankakee
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Facility Name
Illinois CancerCare - Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
La Grange Memorial Hospital
City
La Grange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
North Shore Oncology and Hematology Associates, Limited - Libertyville
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Illinois CancerCare - Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Illinois CancerCare - Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Hematology Oncology Consultants - Naperville
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Cancer Care and Hematology Specialists of Chicagoland - Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare - Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare - Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Illinois CancerCare - Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare - Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Hematology Oncology Associates - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Illinois CancerCare - Spring Valley
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2098
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - Elkhart
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
William N. Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - South Bend
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Michiana Hematology Oncology PC - Plymouth
City
Plymouth
State/Province
Indiana
ZIP/Postal Code
46563
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Michiana Hematology Oncology PC - La Porte
City
Westville
State/Province
Indiana
ZIP/Postal Code
46391
Country
United States
Facility Name
Medical Oncology and Hematology Associates - West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at Mercy Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Veterans Affairs Medical Center - Iowa City
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Facility Name
McCreery Cancer Center at Ottumwa Regional
City
Ottumwa
State/Province
Iowa
ZIP/Postal Code
52501
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51102
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Hays Medical Center
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Hutchinson Hospital Corporation
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Mount Carmel Regional Cancer Center
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
St. Francis Comprehensive Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Mary Bird Perkins Cancer Center - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Medical Center of Louisiana - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
DeCesaris Cancer Institute at Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Veterans Affairs Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Greater Baltimore Medical Center Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
St. Agnes Hospital Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Lahey Clinic Medical Center - Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Jordan Hospital Club Cancer Center
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Commonwealth Hematology-Oncology, PC - Quincy
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Green Bay Oncology, Limited - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Dickinson County Healthcare System
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeside Cancer Specialists, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
MeritCare Bemidji
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
St. Joseph's Medical Center
City
Brainerd
State/Province
Minnesota
ZIP/Postal Code
56401
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Duluth Clinic Cancer Center - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805-1983
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller - Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
HealthEast Cancer Care at St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Minnesota Oncology - Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
Humphrey Cancer Center at North Memorial Outpatient Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422-2900
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Clinic - River Campus
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Coborn Cancer Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Cancer Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Francis Cancer Center at St. Francis Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Willmar Cancer Center at Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology - Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Regional Cancer Center at Singing River Hospital
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Central Care Cancer Center at Carrie J. Babb Cancer Center
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Skaggs Cancer Center at Skaggs Regional Medical Center
City
Branson
State/Province
Missouri
ZIP/Postal Code
65616
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Truman Medical Center - Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Midwest Hematology Oncology Group, Incorporated
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Healthcare Cancer Care
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405-5309
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology at KRMC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
Hunterdon Regional Cancer Center at Hunterdon Medical Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Frederick R. and Betty M. Smith Cancer Treatment Center
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Tucker Center for Cancer Care at Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940-4199
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Dickstein Cancer Treatment Center at White Plains Hospital Center
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Medcenter One Hospital Cancer Care Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
St. Alexius Medical Center Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58502
Country
United States
Facility Name
MeritCare Broadway
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Roger Maris Cancer Center at MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Barberton Citizens Hospital
City
Barberton
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Cleveland Clinic Beachwood Family Health and Surgery Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aultman Cancer Center at Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
MetroHealth Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Cancer Center at Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Cleveland Clinic Cancer Center
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
St. Rita's Medical Center
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Hillcrest Cancer Center at Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
ZIP/Postal Code
43050
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Parma Community General Hospital
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Facility Name
Southern Ohio Medical Center Cancer Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
North Coast Cancer Care, Incorporated
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Cleveland Clinic Foundation - Strongsville
City
Strongsville
State/Province
Ohio
ZIP/Postal Code
44136
Country
United States
Facility Name
Mount Carmel St. Ann's Cancer Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Cleveland Clinic - Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Adams Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Cherry Tree Cancer Center
City
Hanover
State/Province
Pennsylvania
ZIP/Postal Code
17331
Country
United States
Facility Name
Geisinger Hazleton Cancer Center
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Cancer Center of Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
St. Joseph Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19605
Country
United States
Facility Name
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Geisinger Medical Group - Scenery Park
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
CCOP - Main Line Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
York Cancer Center at Apple Hill Medical Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
MBCCOP - Meharry Medical College - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208-3599
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Hospital - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Lynchburg Hematology-Oncology Clinic
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Cascade Cancer Center at Evergreen Hospital Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Pacific Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
West Virginia University Health Sciences Center - Charleston
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Langlade Memorial Hospital
City
Antigo
State/Province
Wisconsin
ZIP/Postal Code
54409
Country
United States
Facility Name
Marshfield Clinic - Chippewa Center
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Marshfield Clinic Cancer Care at Regional Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
UW Cancer Center Johnson Creek
City
Johnson Creek
State/Province
Wisconsin
ZIP/Postal Code
53038
Country
United States
Facility Name
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Dean Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Holy Family Memorial Medical Center Cancer Care Center
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221-1450
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Marinette
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Saint Joseph's Hospital
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Clinic - Lakeland Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Green Bay Oncology, Limited - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Ministry Medical Group at Saint Mary's Hospital
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
Marshfield Clinic - Indianhead Center
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
St. Nicholas Hospital
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Sheboygan
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Marshfield Clinic at Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Saint Michael's Hospital Cancer Center
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Aurora Medical Center
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Two Rivers
City
Two Rivers
State/Province
Wisconsin
ZIP/Postal Code
54241
Country
United States
Facility Name
Marshfield Clinic - Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Oncology Alliance, SC - Milwaukee - West
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Diagnostic and Treatment Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Weston Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Citations:
PubMed Identifier
26244877
Citation
Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. doi: 10.1056/NEJMoa1503747. Epub 2015 Aug 5.
Results Reference
result
PubMed Identifier
34007017
Citation
Lage DE, Michaelson MD, Lee RJ, Greer JA, Temel JS, Sweeney CJ. Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer. Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1181-1188. doi: 10.1038/s41391-021-00389-2. Epub 2021 May 18.
Results Reference
derived
PubMed Identifier
32313142
Citation
Martini A, Pfail J, Montorsi F, Galsky MD, Oh WK. Surrogate endpoints for overall survival for patients with metastatic hormone-sensitive prostate cancer in the CHAARTED trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):638-645. doi: 10.1038/s41391-020-0231-5. Epub 2020 Apr 20.
Results Reference
derived
PubMed Identifier
29522362
Citation
Morgans AK, Chen YH, Sweeney CJ, Jarrard DF, Plimack ER, Gartrell BA, Carducci MA, Hussain M, Garcia JA, Cella D, DiPaola RS, Patrick-Miller LJ. Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer. J Clin Oncol. 2018 Apr 10;36(11):1088-1095. doi: 10.1200/JCO.2017.75.3335. Epub 2018 Mar 9.
Results Reference
derived
PubMed Identifier
29384722
Citation
Kyriakopoulos CE, Chen YH, Carducci MA, Liu G, Jarrard DF, Hahn NM, Shevrin DH, Dreicer R, Hussain M, Eisenberger M, Kohli M, Plimack ER, Vogelzang NJ, Picus J, Cooney MM, Garcia JA, DiPaola RS, Sweeney CJ. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.
Results Reference
derived
PubMed Identifier
29261442
Citation
Harshman LC, Chen YH, Liu G, Carducci MA, Jarrard D, Dreicer R, Hahn N, Garcia JA, Hussain M, Shevrin D, Eisenberger M, Kohli M, Plimack ER, Cooney M, Vogelzang NJ, Picus J, Dipaola R, Sweeney CJ; ECOG-ACRIN 3805 Investigators. Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel. J Clin Oncol. 2018 Feb 1;36(4):376-382. doi: 10.1200/JCO.2017.75.3921. Epub 2017 Dec 20.
Results Reference
derived
PubMed Identifier
28159490
Citation
Scott E. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Department of Medicine; Department of Biostatistics and Computational Biology; Dana-Farber Cancer Institute, Boston; Harvard Medical School, Boston; Johns Hopkins University, Baltimore; University of Wisconsin Carbone Cancer Center; School of Medicine and Public Health; Madison; Fox Chase Cancer Center, Temple University Health System, Philadelphia; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis; Mayo Clinic, Rochester, MN; University Hospitals Case Medical Center, Seidman Cancer Center; Cleveland Clinic Taussig Cancer Institute; Both in Cleveland; University of Virginia Cancer Center, Charlottesville; Comprehensive Cancer Centers of Nevada, Las Vegas; Siteman Cancer Center, Washington University School of Medicine, St. Louis; NorthShore University Health System, Evanston, IL; University of Michigan Comprehensive Cancer Center, Ann Arbor; Rutgers Cancer Institute of New Jersey, New Brunswick.N Engl J Med. 2015 Aug 20;373(8):737-46. [Epub 2015 Aug 5]. doi: 10.1056/NEJMoa1503747. Urol Oncol. 2017 Mar;35(3):123. doi: 10.1016/j.urolonc.2016.12.021. Epub 2017 Feb 1.
Results Reference
derived
Links:
URL
https://nctn-data-archive.nci.nih.gov/
Description
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.
Learn more about this trial
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
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