Abiraterone Acetate and Antiandrogen Therapy with or without Cabazitaxel and Prednisone in Treating Patients with Metastatic, Hormone-Sensitive Prostate Cancer Previously Treated with Docetaxel

< Back to search results
This clinical trial matches:
Show Search Criteria
Status: Active

Description

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with hormone-sensitive prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and / or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer
  • Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/magnetic resonance imaging [MRI] of abdomen/pelvis, bone scintigraphy or NaF PET/CT)
  • Ability to swallow abiraterone acetate tablets as a whole
  • All patients must be receiving standard of care androgen deprivation treatment (surgical castration versus LHRH agonist or antagonist treatment); subjects receiving LHRH agonist or antagonist must continue treatment throughout the time on this study
  • Patients must have castrate serum level of testosterone of < 50 ng/dL (< 1.73 nmol/L)
  • Patients must have progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for PSA, measurable disease or non-measurable (bone) disease during treatment with ADT: * PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, with the final value >= 2.0 ng/mL * Measurable disease (by RECIST 1.1): > 20% increase in the sum of the longest diameters of all measurable lesions or the development of new measurable lesions; the short axis of a target lymph node must be more that 15 mm to be assessed for change in size * Non-measurable (bone) disease: The appearance of two or more new areas of uptake on bone scan (or NaF PET/CT) consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI)
  • Patients may or may not have been treated previously with a nonsteroidal antiandrogen, such as flutamide, bicalutamide or nilutamide; for patients previously treated with an antiandrogen, they must be off treatment for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration and must have shown PSA progression after discontinuing the anti-androgen
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Hemoglobin (HgB) >= 9.0 gr/dL
  • Platelets >= 100,000/mm^3
  • Creatinine < 2.0 mg/dL
  • Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding
  • Patients with resected or irradiated brain metastases or those treated with stereotactic radiation therapy are eligible to enroll, provided that they do not require treatment with steroids that exceeds 10 mg of prednisone daily or equivalent
  • Sexually active males must use an accepted and effective method of double barrier contraception or abstain from sexual intercourse for the duration of their participation in the study and for 26 weeks after the last dose of study drug
  • NaF PET/CT OPTIONAL SUB-STUDY ELIGIBILITY CRITERIA
  • Ability to lie still for imaging
  • Weight =< 300 lbs

Exclusion Criteria

  • Any prior chemotherapy or androgen receptor (AR)-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone acetate, ketoconazole, or enzalutamide); previous treatment with radium-223 or sipuleucel-T is allowed
  • Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate
  • Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy; concurrent treatment with agents to prevent skeletal-related events (such as zoledronic acid or denosumab) will be allowed as long as it was initiated prior to study entry
  • Any medical condition for which prednisone (corticosteroid) is contraindicated
  • If total bilirubin is > upper limit of normal (ULN) (NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is > ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
  • Alanine (ALT) or aspartate (AST) aminotransferase > 1.5 x ULN
  • Active infection requiring treatment with antibiotics
  • History of adrenal insufficiency or hypoaldosteronism
  • Myocardial infarction or arterial thrombotic event within 6 months, heart failure of New York Heart Association class II or higher, uncontrolled angina, severe uncontrolled ventricular arrhythmia
  • External beam radiation therapy within 4 weeks of registration
  • Prior history of allergic reactions to G-CSF
  • Prior history of allergic reactions to docetaxel and/or to medications formulated with polysorbate 80
  • History of active malignancy; patients with a history of cancer that has been adequately treated and are free of disease recurrence for 3 years or more are allowed to participate; patients with non-melanoma skin cancers or carcinoma in situ of the bladder that have been adequately excised are eligible to participate
  • Life expectancy of < 12 months at screening
  • Grade >= 2 neuropathy

Locations & Contacts

Arkansas

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

California

Arroyo Grande
PCR Oncology
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Auburn
Sutter Auburn Faith Hospital
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Cancer Centers Radiation Oncology Services-Auburn
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Burlingame
Mills-Peninsula Medical Center
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Castro Valley
Eden Hospital Medical Center
Status: Active
Contact: Ari David Baron
Phone: 510-537-1234
Davis
Sutter Davis Hospital
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Fremont
Palo Alto Medical Foundation-Fremont
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Modesto
Memorial Medical Center
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Mountain View
Palo Alto Medical Foundation-Camino Division
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Palo Alto Medical Foundation-Gynecologic Oncology
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Novato
Sutter Cancer Research Consortium
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Palo Alto
Palo Alto Medical Foundation Health Care
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Paradise
Feather River Cancer Center
Status: Active
Contact: Sam Mazj
Phone: 530-876-7995 Email: haleew@ah.org
Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sutter Roseville Medical Center
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
San Francisco
California Pacific Medical Center-Pacific Campus
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Santa Rosa
Sutter Pacific Medical Foundation
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: Active
Contact: Ari David Baron
Phone: 415-209-2686 Email: bernicl@sutterhealth.org

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Boulder
Boulder Community Hospital
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: jbloomfield@co-cancerresearch.org
Rocky Mountain Cancer Centers-Boulder
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Penrose
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Denver
Colorado Blood Cancer Institute
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Denver Health Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
National Jewish Health-Main Campus
Status: Active
Contact: Keren Sturtz
Phone: 877-225-5654 Email: glicht@co-cancerresearch.org
Porter Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Presbyterian - Saint Lukes Medical Center - Health One
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Midtown
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Rocky Mountain Cancer Centers-Rose
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Rose Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
SCL Health Saint Joseph Hospital
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
The Women's Imaging Center
Status: Active
Contact: Keren Sturtz Email: ecog.rss@jimmy.harvard.edu
Western Surgical Care
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Durango
Mercy Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Southwest Oncology PC
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Englewood
Comprehensive Cancer Care and Research Institute of Colorado LLC
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Swedish Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Golden
Mountain Blue Cancer Care Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
National Jewish Health-Western Hematology Oncology
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: glicht@co-cancerresearch.org
Grand Junction
Grand Valley Oncology
Status: Temporarily closed to accrual
Contact: Benjamin L. Maughan
Phone: 970-644-4460 Email: gvoclinicaltrials@gjhosp.org
Saint Mary's Hospital and Regional Medical Center
Status: Active
Contact: Keren Sturtz Email: ecog.rss@jimmy.harvard.edu
Greeley
North Colorado Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Lafayette
Good Samaritan Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-673-1622
Lakewood
Rocky Mountain Cancer Centers-Lakewood
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Saint Anthony Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Littleton
Littleton Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Littleton
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Longmont
Longmont United Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Longmont
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Loveland
McKee Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Parker
Parker Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Parker
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Pueblo
Rocky Mountain Cancer Centers - Pueblo
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Saint Mary Corwin Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Thornton
National Jewish Health-Northern Hematology Oncology
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: glicht@co-cancerresearch.org
Rocky Mountain Cancer Centers-Thornton
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org

Connecticut

Middletown
Middlesex Hospital
Status: Active
Contact: Susanna Hong
Phone: 860-358-2058 Email: beth_slifer@midhosp.org

District of Columbia

Washington
Sibley Memorial Hospital
Status: Active
Contact: Channing J. Paller
Phone: 202-243-2373 Email: jquiver1@jhmi.edu

Idaho

Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Priyank P. Patel
Phone: 630-978-6212 Email: Cancer.Research@rushcopley.com
Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: Active
Contact: Bryan A. Faller
Phone: 618-457-5200 Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: Active
Contact: Bryan A. Faller
Phone: 618-985-3333 Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Danville
Carle on Vermilion
Status: Active
Contact: Priyank P. Patel
Phone: 800-446-5532 Email: Research@carle.com
Decatur
Cancer Care Specialists of Central Illinois
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Priyank P. Patel
Phone: 800-446-5532 Email: Research@carle.com
Crossroads Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-344-2831
Joliet
Joliet Oncology-Hematology Associates Limited
Status: Active
Contact: Nafisa D. Burhani
Phone: 815-730-3098 Email: maureenc@jolietoncology.com
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Priyank P. Patel
Phone: 800-446-5532 Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Status: Active
Contact: Jay W. Carlson
Phone: 618-242-4600
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: Active
Contact: Bryan A. Faller
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: Active
Contact: Bryan A. Faller
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Memorial and Saint Elizabeth's Health Care Services LLP
Status: Active
Contact: Bryan A. Faller Email: ecog.rss@jimmy.harvard.edu
Urbana
Carle Cancer Center
Status: Active
Contact: Priyank P. Patel
Phone: 800-446-5532 Email: Research@carle.com
The Carle Foundation Hospital
Status: Active
Contact: Priyank P. Patel
Phone: 800-446-5532 Email: Research@carle.com
Yorkville
Rush-Copley Healthcare Center
Status: Active
Contact: Priyank P. Patel
Phone: 630-978-6212 Email: Cancer.Research@rushcopley.com

Indiana

Fort Wayne
Parkview Hospital Randallia
Status: Active
Contact: Zhentao Zhang
Phone: 260-373-8888 Email: parkviewresearch@parkview.com
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Nabil Adra
Phone: 317-278-5632 Email: iutrials@iu.edu
Sidney and Lois Eskenazi Hospital
Status: Active
Contact: Nabil Adra
Phone: 317-278-5632 Email: iutrials@iu.edu
Mishawaka
Memorial Regional Cancer Center Day Road
Status: Active
Contact: Thomas Joseph Reid
Phone: 888-823-5923 Email: ctsucontact@westat.com
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Thomas Joseph Reid
Phone: 800-284-7370

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Council Bluffs
Alegent Health Mercy Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Creston
Greater Regional Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Kansas

Garden City
Central Care Cancer Center - Garden City
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Minimally Invasive Surgery Hospital
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Overland Park
Menorah Medical Center
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org

Kentucky

Bardstown
Flaget Memorial Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Corbin
Commonwealth Cancer Center-Corbin
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Lexington
Saint Joseph Hospital East
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Saint Joseph Radiation Oncology Resource Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
London
Saint Joseph London
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Louisville
Jewish Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Jewish Hospital Medical Center Northeast
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Saints Mary and Elizabeth Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Shepherdsville
Jewish Hospital Medical Center South
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Channing J. Paller
Phone: 410-955-8804 Email: jhcccro@jhmi.edu

Michigan

Adrian
Hickman Cancer Center
Status: Active
Contact: Rex B. Mowat
Phone: 517-265-0116
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: Active
Contact: Rex B. Mowat
Phone: 800-444-3561
Port Huron
Huron Medical Center PC
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Lake Huron Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org

Minnesota

Bemidji
Sanford Clinic North-Bemidgi
Status: Active
Contact: Preston D. Steen
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: David Mark King Email: ecog.rss@jimmy.harvard.edu
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com
Wyoming
Fairview Lakes Medical Center
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: Active
Contact: Jay W. Carlson
Phone: 314-251-7058
Bolivar
Central Care Cancer Center - Bolivar
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Bonne Terre
Parkland Health Center-Bonne Terre
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Branson
Cox Cancer Center Branson
Status: Active
Contact: Jay W. Carlson
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 573-334-2230 Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Joel Picus
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Independence
Centerpoint Medical Center LLC
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Jefferson City
Capital Region Southwest Campus
Status: Active
Contact: Bryan A. Faller
Phone: 573-632-4814 Email: swooden@mail.crmc.org
Joplin
Freeman Health System
Status: Active
Contact: Jay W. Carlson
Phone: 417-347-4030 Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Status: Active
Contact: Jay W. Carlson
Phone: 417-556-3074 Email: esmeralda.carrillo@mercy.net
Kansas City
Research Medical Center
Status: Active
Contact: Rakesh Gaur
Phone: 913-948-5588 Email: aroland@kccop.org
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Jay W. Carlson
Phone: 573-458-7504 Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Active
Contact: Jay W. Carlson
Phone: 573-458-7504 Email: jrichards@research.pcrmc.com
Saint Joseph
Heartland Regional Medical Center
Status: Active
Contact: Jay W. Carlson
Phone: 816-271-7937 Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Jay W. Carlson
Phone: 314-251-6770
Missouri Baptist Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: Active
Contact: Jay W. Carlson
Phone: 314-353-1870
Siteman Cancer Center at Christian Hospital
Status: Active
Contact: Joel Picus
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Status: Active
Contact: Joel Picus
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Joel Picus
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Joel Picus
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: Active
Contact: Jay W. Carlson
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Jay W. Carlson
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: Active
Contact: Jay W. Carlson
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 800-996-2663 Email: research@billingsclinic.org
Saint Vincent Frontier Cancer Center
Status: Active
Contact: Keren Sturtz
Phone: 800-648-6274
Saint Vincent Healthcare
Status: Active
Contact: Keren Sturtz
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Active
Contact: Benjamin T. Marchello Email: ecog.rss@jimmy.harvard.edu
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Kearney
CHI Health Good Samaritan
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Heartland Hematology and Oncology
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Lincoln
Saint Elizabeth Regional Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Alegent Health Immanuel Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Alegent Health Lakeside Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Creighton University Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Hematology and Oncology Consultants PC
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Papillion
Midlands Community Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Henderson
21st Century Oncology-Henderson
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Cancer and Blood Specialists-Henderson
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Henderson
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Las Vegas Cancer Center-Henderson
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Nevada Cancer Specialists-Saint Rose
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Las Vegas
21st Century Oncology
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
21st Century Oncology-Fort Apache
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
21st Century Oncology-Vegas Tenaya
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Ann M Wierman MD LTD
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Cancer and Blood Specialists-Shadow
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Cancer and Blood Specialists-Tenaya
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Cancer Therapy and Integrative Medicine
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Central Valley
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada - Northwest
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Comprehensive Cancer Centers of Nevada-Summerlin
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Desert West Surgery
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Las Vegas Cancer Center-Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Nevada Cancer Specialists?Oakey
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Nevada Cancer Specialists-Fort Apache
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Nevada Cancer Specialists-Tenaya
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Radiation Oncology Centers of Nevada Central
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Radiation Oncology Centers of Nevada Southeast
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Summerlin Hospital Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
University Cancer Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Reno
Radiation Oncology Associates
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Renown Regional Medical Center
Status: Active
Contact: John Allan Ellerton
Phone: 702-384-0013 Email: research@sncrf.org
Saint Mary's Regional Medical Center
Status: Active
Contact: John Allan Ellerton Email: ecog.rss@jimmy.harvard.edu

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Benjamin Adam Gartrell
Phone: 718-379-6862 Email: sforde@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Benjamin Adam Gartrell
Phone: 718-379-6862 Email: sforde@montefiore.org
Montefiore Medical Center-Weiler Hospital
Status: Active
Contact: Benjamin Adam Gartrell
Phone: 718-379-6862 Email: sforde@montefiore.org

North Carolina

Clinton
Southeastern Medical Oncology Center-Clinton
Status: Active
Contact: James N. Atkins
Phone: 919-587-9077 Email: ecooke@cancersmoc.com
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: Active
Contact: James N. Atkins
Phone: 919-587-9077 Email: ecooke@cancersmoc.com
Wayne Memorial Hospital
Status: Active
Contact: James N. Atkins
Phone: 919-731-6687 Email: ecooke@cancersmoc.com
Jacksonville
Onslow Memorial Hospital
Status: Active
Contact: James N. Atkins
Phone: 910-353-0824 Email: ecooke@cancersmoc.com
Southeastern Medical Oncology Center-Jacksonville
Status: Active
Contact: James N. Atkins
Phone: 910-353-0824 Email: ecooke@cancersmoc.com
Kinston
Vidant Oncology-Kinston
Status: Active
Contact: Peter Robins Watson
Phone: 252-559-2200

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Preston D. Steen
Phone: 701-323-5760 Email: tamara.fischer@sanfordhealth.org
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Preston D. Steen
Phone: 701-234-6161
Sanford Broadway Medical Center
Status: Active
Contact: Preston D. Steen
Phone: 800-437-4010

Ohio

Cincinnati
Bethesda North Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Good Samaritan Hospital - Cincinnati
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Anderson
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Westside
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Maumee
Toledo Clinic Cancer Centers-Maumee
Status: Active
Contact: Rex B. Mowat Email: ecog.rss@jimmy.harvard.edu
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Status: Active
Contact: Rex B. Mowat
Phone: 419-891-5600ext4
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: Active
Contact: Rex B. Mowat
Phone: 419-479-5605 Email: pshoup@toledoclinic.com
Toledo
Mercy Saint Anne Hospital
Status: Active
Contact: Rex B. Mowat
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: Active
Contact: Rex B. Mowat
Phone: 800-444-3561

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: Active
Contact: Abhishek Tripathi
Phone: 877-231-4440
Oklahoma City
Mercy Hospital Oklahoma City
Status: Active
Contact: Jay W. Carlson
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: Active
Contact: Abhishek Tripathi
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: Active
Contact: Abhishek Tripathi
Phone: 918-505-3200

Pennsylvania

Beaver
UPMC-Heritage Valley Health System Beaver
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 724-773-7616
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 724-838-1900
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 717-724-6765 Email: klitchfield@PINNACLEHEALTH.org
Johnstown
UPMC-Johnstown / John P. Murtha Regional Cancer Center
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 814-534-4724
McKeesport
UPMC Cancer Center at UPMC McKeesport
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-647-8073
Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-604-2020
Philadelphia
ECOG-ACRIN Cancer Research Group
Status: Active
Contact: Christos Kyriakopoulos Email: ckyriako@medicine.wisc.edu
Temple University Hospital
Status: Active
Contact: Alvaro Pereira-Rico
Phone: 215-728-2983
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Vivek K. Narayan
Phone: 800-474-9892
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Leonard Joseph Appleman
Phone: 412-647-8073
UPMC-Magee Womens Hospital
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-647-2811
UPMC-Passavant Hospital
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-367-6454
UPMC-Presbyterian Hospital
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-647-2811
UPMC-Saint Clair Hospital Cancer Center
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-502-3920
UPMC-Saint Margaret
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-784-4900
UPMC-Shadyside Hospital
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 412-621-2334
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: Active
Contact: Philip Andrew Lowry
Phone: 800-836-0388
Seneca
UPMC Cancer Center at UPMC Northwest
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 814-676-7900
Uniontown
UPMC Uniontown Hospital Radiation Oncology
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 724-437-2503
Washington
UPMC Washington Hospital Radiation Oncology
Status: Temporarily closed to accrual
Contact: Leonard Joseph Appleman
Phone: 724-223-3788 Email: cancer@washingtonhospital.org
West Reading
Reading Hospital
Status: Active
Contact: Terrence Paul Cescon
Phone: 610-988-9323
Williamsport
UPMC Susquehanna
Status: Active
Contact: Leonard Joseph Appleman
Phone: 800-598-4282

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Preston D. Steen
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Preston D. Steen
Phone: 605-312-3320 Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Bristol
Wellmont Bristol Regional Medical Center
Status: Active
Contact: Asheesh Shipstone
Phone: 423-578-8538 Email: justin.reynolds@wellmont.org
Chattanooga
Memorial Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Johnson City
Wellmont Medical Associates Oncology and Hematology-Johnson City
Status: Active
Contact: Asheesh Shipstone
Phone: 423-578-8538 Email: justin.reynolds@wellmont.org
Kingsport
Wellmont Holston Valley Hospital and Medical Center
Status: Active
Contact: Asheesh Shipstone
Phone: 423-578-8538 Email: justin.reynolds@wellmont.org
Wellmont Medical Associates Oncology and Hematology-Kingsport
Status: Active
Contact: Asheesh Shipstone
Phone: 423-578-8538 Email: justin.reynolds@wellmont.org
Ooltewah
Memorial GYN Plus
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Utah

Farmington
Farmington Health Center
Status: Active
Contact: Benjamin L. Maughan
Phone: 888-424-2100 Email: cancerinfo@hci.utah.edu
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Benjamin L. Maughan
Phone: 888-424-2100 Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Status: Active
Contact: Benjamin L. Maughan
Phone: 888-424-2100 Email: cancerinfo@hci.utah.edu

Virginia

Bristol
Wellmont Medical Associates-Bristol
Status: Active
Contact: Asheesh Shipstone
Phone: 423-578-8538 Email: justin.reynolds@wellmont.org
Norton
Southwest VA Regional Cancer Center
Status: Active
Contact: Asheesh Shipstone
Phone: 423-578-8538 Email: justin.reynolds@wellmont.org

Washington

Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Harrison Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Status: Temporarily closed to accrual
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Enumclaw
Saint Elizabeth Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Federal Way
Saint Francis Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Lakewood
Saint Clare Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Northwest Medical Specialties PLLC
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org

Wisconsin

Johnson Creek
UW Cancer Center Johnson Creek
Status: Active
Contact: Christos Kyriakopoulos
Phone: 920-699-3500 Email: lynda.persico@uwmf.wisc.edu
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Christos Kyriakopoulos
Phone: 800-622-8922
New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: David Mark King
Phone: 952-993-1517 Email: mmcorc@healthpartners.com

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: Active
Contact: Keren Sturtz
Phone: 303-777-2663 Email: ccrp@co-cancerresearch.org
Cody
Billings Clinic-Cody
Status: Active
Contact: Benjamin T. Marchello
Phone: 800-996-2663 Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Active
Contact: Benjamin T. Marchello
Phone: 406-969-6060 Email: mccinfo@mtcancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with castration-resistant prostate cancer (CRPC) that have previously received docetaxel and androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer (HSPC) can improve progression-free survival (PFS) compared to abiraterone acetate alone.

SECONDARY OBJECTIVES:

I. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can increase the percentage of change in prostate-specific antigen (PSA) from baseline to week 12 of treatment as well as the maximum decline in PSA that occurs at any point after treatment compared to abiraterone acetate alone.

II. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel for HSPC can prolong time to PSA progression compared to abiraterone acetate alone.

III. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel for HSPC can improve radiographic response (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) compared to abiraterone acetate alone.

IV. To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can prolong the overall survival (OS) compared to abiraterone acetate alone.

V. To assess safety and tolerability of the combination of 6 cycles of cabazitaxel and abiraterone acetate.

TERTIARY OBJECTIVES:

I. To examine whether patients with circulating tumor cells (CTCs) positive for AR-V7 at baseline have a longer radiographic or clinical PFS to the combination of cabazitaxel and abiraterone acetate vs. abiraterone acetate alone.

II. To examine whether the addition of cabazitaxel to abiraterone acetate can change the AR-V7 status of patients who are positive at study entry.

III. To examine whether the addition of cabazitaxel to abiraterone acetate has any impact on future development of AR-V7 positivity at the time of disease progression.

IV. To assess if the changes in total tumor burden from baseline to week 12 as assessed with sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) will differ between two arms.

V. To correlate total tumor burden at the baseline as assessed with NaF PET/CT with the PFS.

VI. To correlate heterogeneity of response from baseline to week 12 as assessed with NaF PET/CT with the PFS.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive abiraterone acetate orally (PO) once daily (QD) on days 1-21, prednisone PO twice daily (BID) on days 1-21. Courses of abiraterone acetate and prednisone repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive cabazitaxel intravenously (IV) over 1 hour on day 1, and treatment with cabazitaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care antiandrogen therapy with either luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or surgical castration with bilateral orchiectomy.

ARM B: Patients receive abiraterone acetate and prednisone as in Arm A. Patients also receive standard of care antiandrogen therapy with either LHRH agonist or antagonist, or surgical castration with bilateral orchiectomy.

After completion of study treatment, patients are followed up every 3 or 6 months and then annually for up to 5 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Christos Kyriakopoulos

Trial IDs

Primary ID EA8153
Secondary IDs NCI-2017-00389
Clinicaltrials.gov ID NCT03419234