A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

NCT ID: NCT03574571

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2027-04-01

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Docetaxel 75 mg/m2

Intervention Type: DRUG

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.

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.

Group Type: EXPERIMENTAL

Docetaxel 60 mg/m2

Intervention Type: DRUG

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.

Radium-223

Intervention Type: DRUG

Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Interventions

Docetaxel 75 mg/m2

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.

Intervention Type: DRUG

Docetaxel 60 mg/m2

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.

Intervention Type: DRUG

Radium-223

Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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.

2. 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.

3. 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

Exclusion Criteria

• 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.
• Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
• Has imminent or established cord compression based on clinical findings and/or MRI.
• Known bone marrow dysplasia
• Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
• Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:

• Uncontrolled infection
• NYHA III or IV heart failure
• Crohn's disease or those with ulcerative colitis who have not undergone a colectomy
• Known active infection with HIV, Hepatitis B or Hepatitis C

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Yale University- Yale Cancer Center

New Haven, Connecticut, United States

Helen Graham Cancer Center (Christiana Care)

Newark, Delaware, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Mount Sinai Medical Center (Miami)

Miami, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Ochsner Cancer Institute

New Orleans, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

University of Massachusetts

Worcester, Massachusetts, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

New Jersey Urology

Saddle Brook, New Jersey, United States

New Mexico Oncology and Hematology

Albuquerque, New Mexico, United States

University of Buffalo

Buffalo, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, United States

Bronx VA Hospital

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Atrium Health/ Levine Cancer Institute

Monroe, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Dayton Physicians Network

Kettering, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Houston Methodist Research Institute

Houston, Texas, United States

Millennium Physicians

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Hospital de Amor de Barretos (Fundação Pio XII) / Barretos Cancer Hospital

Barretos, Dr. Paulo Prata, Brazil

Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

Boa Vista, Pernambuco, Brazil

Instituto Brasileiro de Controle do Câncer/IBCC

São Paulo, State of São Paulo, Brazil

Hospital Sírio Libanês

Brasília, , Brazil

Hospital Erasto Gaertner

Curitiba, , Brazil

CPORS - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, , Brazil

Hospital Moinhos de Vento (HMV)

Porto Alegre, , Brazil

Hospital Israelita Albert Einstein

São Paulo, , 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, Netherlands

Noordwest Ziekenhuisgrouep Alkmaar (NWZ)

Alkmaar, , Netherlands

Ziekenhuisgroep Twente (ZGT)

Almelo, , Netherlands

Amphia Hospital

Breda, , Netherlands

Deventer Ziekenhuis

Deventer, , Netherlands

Tergooi Hospital

Hilversum, , Netherlands

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, , Netherlands

Erasmus MC Cancer Institute

Rotterdam, , Netherlands

Franciscus Gasthuis & Vlietland

Rotterdam, , Netherlands

Maasstad Hospital

Rotterdam, , Netherlands

Haaglanden Medical Center

The Hague, , Netherlands

St. Antonius Ziekenhuis (Utrecht)

Utrecht, , Netherlands

Isala Kliniek

Zwolle, , Netherlands

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Avenida de Roma S/n, Spain

Ramón y Cajal Hospital

Madrid, Madrid, Spain

Hospital Del Mar

Barcelona, , Spain

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, , Spain

Clinic de Barcelona

Barcelona, , Spain

Hospital Provincial de Castellón

Castellon, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Virgen Del Rocío

Seville, , Spain

Instituto Valenciano de Oncología

Valencia, , Spain

Countries

United States; Brazil; Netherlands; Spain

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

2018-002944-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18-150

Identifier Type: -

Identifier Source: org_study_id