A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer
Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
2 other identifiers
interventional
732
4 countries
72
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Jun 2018
Typical duration for phase_3 prostate-cancer
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2018
CompletedFirst Submitted
Initial submission to the registry
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 27, 2026
February 1, 2026
8.8 years
June 20, 2018
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival is defined as the time from randomization to death from any cause.
2 years
Study Arms (2)
Docetaxel
EXPERIMENTALDocetaxel 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.
Docetaxel with Radium-223
EXPERIMENTALDocetaxel 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.
Interventions
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
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.
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
You may not qualify if:
- Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
- °Note: If this requirement to have a washout of 2 weeks or 5 half-lives prior to randomization causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at pcctc@mskcc.org to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start.
- Received external beam radiotherapy within the 4 weeks prior to randomization.
- ° Note: If prolonging randomization to complete EBRT washout causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at pcctc@mskcc.org to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start.
- Has an immediate need for external beam radiotherapy.
- Has received any systemic bone-seeking radiopharmaceutical in the past.
- Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
- Has received four or more systemic anticancer regimens for mCRPC.
- Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
- A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
- Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
- Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
- Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
- Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
- Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Bayercollaborator
Study Sites (72)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Yale University- Yale Cancer Center
New Haven, Connecticut, 06510, United States
Helen Graham Cancer Center (Christiana Care)
Newark, Delaware, 19713, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Mount Sinai Medical Center (Miami)
Miami, Florida, 33140, United States
Rush University Medical Center
Chicago, Illinois, 606012, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68114, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
New Jersey Urology
Saddle Brook, New Jersey, 07663, United States
New Mexico Oncology and Hematology
Albuquerque, New Mexico, 87109, United States
University of Buffalo
Buffalo, New York, 14203, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10065, United States
Bronx VA Hospital
New York, New York, 10468, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Atrium Health/ Levine Cancer Institute
Monroe, North Carolina, 28112, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Dayton Physicians Network
Kettering, Ohio, 45409, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Millennium Physicians
Houston, Texas, 77090, United States
University of Washington
Seattle, Washington, 98109, United States
Hospital de Amor de Barretos (Fundação Pio XII) / Barretos Cancer Hospital
Barretos, Dr. Paulo Prata, 14784-400, Brazil
Instituto de Medicina Integral Professor Fernando Figueira (IMIP)
Boa Vista, Pernambuco, 50.070-902, Brazil
Instituto Brasileiro de Controle do Câncer/IBCC
São Paulo, State of São Paulo, Brazil
Hospital Sírio Libanês
Brasília, 70200-730, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
CPORS - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Porto Alegre, 90610000, Brazil
Hospital Moinhos de Vento (HMV)
Porto Alegre, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05652-900, Brazil
Beneficência Portuguesa
São Paulo, Brazil
Centro de Pesquisas São Lucas - Sociedade Campineira de Educação e Instrução (SCEI)
São Paulo, Brazil
Nederlands Kanker Instituut
Amsterdam, Plesmanlaan, 1066 CX, Netherlands
Noordwest Ziekenhuisgrouep Alkmaar (NWZ)
Alkmaar, 1815, Netherlands
Ziekenhuisgroep Twente (ZGT)
Almelo, 7609, Netherlands
Amphia Hospital
Breda, 4818, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Tergooi Hospital
Hilversum, 1213, Netherlands
Canisius Wilhelmina Ziekenhuis (CWZ)
Nijmegen, 6532, Netherlands
Erasmus MC Cancer Institute
Rotterdam, 3015 GD, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, 3045, Netherlands
Maasstad Hospital
Rotterdam, 3079, Netherlands
Haaglanden Medical Center
The Hague, 2512, Netherlands
St. Antonius Ziekenhuis (Utrecht)
Utrecht, Netherlands
Isala Kliniek
Zwolle, 8025, Netherlands
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Avenida de Roma S/n, 33011, Spain
Ramón y Cajal Hospital
Madrid, Madrid, 28034, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, 08035, Spain
Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Provincial de Castellón
Castellon, 12006, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen Del Rocío
Seville, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Morris, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2018
First Posted
July 2, 2018
Study Start
June 19, 2018
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02