Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Who is this study for? Adult patients with prostate cancer
Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.

• NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.

• Males 18 years of age and above

• Histological or cytological proof of prostate cancer

• Documented progressive mCRPC based on at least one of the following criteria:

∙ PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL.

‣ Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.

‣ Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.

• Two or more bone lesions

• ECOG 0- 1

• Normal organ function with acceptable initial laboratory values within 14 days of randomization:

‣ Albumin \> 30 g/L

⁃ ANC ≥ 1.5 x 10\^9/L

⁃ Hemoglobin ≥ 10 g/dL

⁃ Platelet count ≥ 100 x 10\^9/L

⁃ Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)

⁃ Bilirubin ≤ ULN (unless documented Gilbert's disease)

⁃ SGOT (AST) ≤ 1.5 x ULN

⁃ SGPT (ALT) ≤ 1.5 x ULN

⁃ WBC count ≥ 3 x 10\^9/L

• Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

• Serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.

• All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.

• Willing and able to comply with the protocol, including follow-up visits and examinations

Locations
United States
Arizona
Banner MD Anderson Cancer Center
COMPLETED
Gilbert
Connecticut
Yale University- Yale Cancer Center
RECRUITING
New Haven
Delaware
Helen Graham Cancer Center (Christiana Care)
RECRUITING
Newark
Florida
Boca Raton Regional Hospital
ACTIVE_NOT_RECRUITING
Boca Raton
Mount Sinai Medical Center (Miami)
RECRUITING
Miami
Illinois
Rush University Medical Center
RECRUITING
Chicago
Indiana
Indiana University
RECRUITING
Indianapolis
Louisiana
Ochsner Cancer Institute
RECRUITING
New Orleans
Massachusetts
University of Massachusetts
RECRUITING
Worcester
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Michigan
University of Michigan Cancer Center
COMPLETED
Ann Arbor
Minnesota
University of Minnesota
ACTIVE_NOT_RECRUITING
Minneapolis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Atrium Health/ Levine Cancer Institute
ACTIVE_NOT_RECRUITING
Monroe
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
XCancer Omaha / Urology Cancer Center
COMPLETED
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
MD Anderson Cancer Center at Cooper
COMPLETED
Camden
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
New Jersey Urology
ACTIVE_NOT_RECRUITING
Saddle Brook
New Mexico
New Mexico Oncology and Hematology
RECRUITING
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
New York
Roswell Park Cancer Institute
COMPLETED
Buffalo
University of Buffalo
RECRUITING
Buffalo
Memorial Sloan Kettering Commack
RECRUITING
Commack
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Bronx VA Hospital
COMPLETED
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
New York Presbyterian Hospital-Weill Medical College of Cornell University
ACTIVE_NOT_RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Dayton Physicians Network
ACTIVE_NOT_RECRUITING
Kettering
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
MidLantic Urology
RECRUITING
Bala-cynwyd
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Houston Methodist Research Institute
ACTIVE_NOT_RECRUITING
Houston
Millennium Physicians
ACTIVE_NOT_RECRUITING
Houston
Washington
University of Washington
COMPLETED
Seattle
Other Locations
Brazil
Hospital de Amor de Barretos (Fundação Pio XII) / Barretos Cancer Hospital
RECRUITING
Barretos
Instituto de Medicina Integral Professor Fernando Figueira (IMIP)
RECRUITING
Boa Vista
Hospital Sírio Libanês
RECRUITING
Brasília
Hospital Erasto Gaertner
RECRUITING
Curitiba
CPORS - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
Hospital Moinhos de Vento (HMV)
RECRUITING
Porto Alegre
Beneficência Portuguesa
RECRUITING
São Paulo
Centro de Pesquisas São Lucas - Sociedade Campineira de Educação e Instrução (SCEI)
RECRUITING
São Paulo
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Instituto Brasileiro de Controle do Câncer/IBCC
RECRUITING
São Paulo
Netherlands
Noordwest Ziekenhuisgrouep Alkmaar (NWZ)
RECRUITING
Alkmaar
Ziekenhuisgroep Twente (ZGT)
RECRUITING
Almelo
Nederlands Kanker Instituut
RECRUITING
Amsterdam
Amphia Hospital
RECRUITING
Breda
Deventer Ziekenhuis
RECRUITING
Deventer
Tergooi Hospital
RECRUITING
Hilversum
Canisius Wilhelmina Ziekenhuis (CWZ)
RECRUITING
Nijmegen
Erasmus MC Cancer Institute
RECRUITING
Rotterdam
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Maasstad Hospital
RECRUITING
Rotterdam
Haaglanden Medical Center
RECRUITING
The Hague
St. Antonius Ziekenhuis (Utrecht)
RECRUITING
Utrecht
Isala Kliniek
RECRUITING
Zwolle
Spain
Clinic de Barcelona
RECRUITING
Barcelona
Hospital Del Mar
RECRUITING
Barcelona
Vall d'Hebron Institute of Oncology (VHIO)
RECRUITING
Barcelona
Hospital Provincial de Castellón
COMPLETED
Castellon
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Ramón y Cajal Hospital
RECRUITING
Madrid
Hospital Universitario Central de Asturias (HUCA)
RECRUITING
Oviedo
Hospital Universitario Virgen Del Rocío
RECRUITING
Seville
Instituto Valenciano de Oncología
RECRUITING
Valencia
Contact Information
Primary
Michael Morris, MD
morrism@mskcc.org
646-422-4469
Backup
Josef Fox, MD
212-639-7371
Time Frame
Start Date: 2018-06-19
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 738
Treatments
Experimental: Docetaxel
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.
Experimental: Docetaxel with Radium-223
Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.
Related Therapeutic Areas
Sponsors
Collaborators: Bayer
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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