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

April 9, 2024 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

738

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Josef Fox, MD
  • Phone Number: 212-639-7371

Study Locations

  • Brazil
    • State Of São Paulo
      • São Paulo, State Of São Paulo, Brazil
        • Recruiting
        • Instituto Brasileiro de Controle do Câncer/IBCC
        • Contact:
  • Netherlands
      • Alkmaar, Netherlands, 1815
        • Recruiting
        • Noordwest Ziekenhuisgrouep Alkmaar (NWZ)
        • Contact:
          • M. Hendriks, MD
          • Phone Number: +31 72 5482872
      • Almelo, Netherlands, 7609
        • Recruiting
        • Ziekenhuisgroep Twente (ZGT)
        • Contact:
      • Breda, Netherlands, 4818
      • Den Haag, Netherlands, 2512
      • Deventer, Netherlands
        • Recruiting
        • Deventer Ziekenhuis
        • Contact:
      • Hilversum, Netherlands, 1213
      • Nijmegen, Netherlands, 6532
      • Rotterdam, Netherlands, 3015 GD
      • Rotterdam, Netherlands, 3045
      • Rotterdam, Netherlands, 3079
      • Utrecht, Netherlands
      • Zwolle, Netherlands, 8025
    • Plesmanlaan 121
      • Amsterdam, Plesmanlaan 121, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut (Data Collection Only)
        • Contact:
          • Andre Bergman, MD
          • Phone Number: +31 20 512 2046
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital Del Mar (Data Collection Only)
        • Contact:
          • Alejo Rodriguez-Vida, MD, PhD
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology (VHIO) (Data Collection Only)
        • Contact:
          • Macarena Gonzalez, MD
          • Phone Number: 34 934 89 30 00
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre (Data Collection Only)
        • Contact:
          • David Olmos, MBBS, MSc, PhD
          • Phone Number: +34 913 90 80 00
      • Sevilla, Spain
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO (Data Collection Only)
        • Contact:
          • Begona Perez-Valderrama, MD
          • Phone Number: 0034 955 013 068
      • Valencia, Spain
        • Recruiting
        • Instituto Valenciano de Oncología (Data Collection Only)
        • Contact:
          • María José Juan-Fita, MD, PhD
          • Phone Number: +34 961 11 40 00
    • Community Of Madrid
      • Madrid, Community Of Madrid, Spain, 28034
        • Recruiting
        • Ramón y Cajal Hospital
        • Contact:
          • Teresa Alonso-Gordoa, MD
          • Phone Number: +34 913 36 80 00
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Completed
        • Banner MD Anderson Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University- Yale Cancer Center
        • Contact:
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen Graham Cancer Center (Christiana Care)
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Boca Raton Regional Hospital
        • Contact:
          • Alan Koletsky, MD
          • Phone Number: 561-955-6400
      • Miami, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center (Miami)
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 606012
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Dian Wang, MD, PhD
          • Phone Number: 312-942-5751
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Nabil Adra, MD
          • Phone Number: 317-944-5349
          • Email: nadra@iu.edu
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Cancer Institute
        • Contact:
          • Marc Matrana, MD
          • Phone Number: 504-842-3910
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
          • Arif Hussain, MD
          • Phone Number: 410-328-7225
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Contact:
          • Kriti Mittal, MD, MS
          • Phone Number: 508-334-3550
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Completed
        • University of Michigan Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
          • Gautam Jha, MD
          • Phone Number: 612-884-0600
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists
        • Contact:
          • Ralph Hauke, MD, FACP
          • Phone Number: 402-354-8124
      • Omaha, Nebraska, United States, 68130
        • Active, not recruiting
        • XCancer Omaha / Urology Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89128
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
      • Camden, New Jersey, United States, 08103
        • Completed
        • MD Anderson Cancer Center at Cooper
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
      • Saddle Brook, New Jersey, United States, 07663
        • Recruiting
        • New Jersey Urology
        • Contact:
          • Elan Diamond, MD
          • Phone Number: 973-873-7029
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • New Mexico Oncology and Hematology
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University of Buffalo
        • Contact:
          • Roberto Pili, MD
          • Phone Number: 716-898-4328
      • Buffalo, New York, United States, 14263-0001
        • Completed
        • Roswell Park Cancer Institute
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Josef Fox, MD
          • Phone Number: 212-639-7371
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
        • Principal Investigator:
          • Michael Morris, MD
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian Hospital-Weill Medical College of Cornell University
        • Contact:
          • Scott Tagawa, MD
          • Phone Number: 646-962-2072
      • New York, New York, United States, 10468
        • Recruiting
        • Bronx VA Hospital
        • Contact:
          • Antonio Fojo, MD, PhD
          • Phone Number: 6669 718-584-9000
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
          • Chunkit Fung, MD
          • Phone Number: 585-275-5823
      • Rockville Centre, New York, United States, 11570
        • Recruiting
        • Memorial Sloan Kettering Rockville Centre
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Michael Morris, MD
          • Phone Number: 646-422-4469
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina
        • Contact:
          • Young Whang, MD, PhD
          • Phone Number: 984-974-0000
      • Monroe, North Carolina, United States, 28112
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
      • Kettering, Ohio, United States, 45409
        • Active, not recruiting
        • Dayton Physicians Network
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology
        • Contact:
          • Laurence Belkoff, DO
          • Phone Number: 610-667-3020
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Houston, Texas, United States, 77090
        • Recruiting
        • Millennium Physicians
        • Contact:
          • Umang Patel, MD
          • Phone Number: 281-440-5006
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Houston Methodist Research Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Completed
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • Received external beam radiotherapy within the 4 weeks prior to randomization.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
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.
Drug: Docetaxel 60 mg/m2
Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.
Drug: Radium-223
Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
Overall survival is defined as the time from randomization to death from any cause.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Bayer

Investigators

  • Principal Investigator: Michael Morris, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-150
  • 2018-002944-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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