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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03574571
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel 75 mg/m2 Drug: Docetaxel 60 mg/m2 Drug: Radium-223 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    Overall survival is defined as the time from randomization to death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate
Accepts Healthy Volunteers:   No
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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574571


Contacts
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Contact: Michael Morris, MD 646-422-4469 morrism@mskcc.org
Contact: Josef Fox, MD 212-639-7371

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Locations
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United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Michael Hurwitz, MD, MPH, MsC         
United States, Delaware
Helen Graham Cancer Center (Christiana Care) Not yet recruiting
Newark, Delaware, United States, 19713
Contact: Michael Guarino, MD    302-366-1200      
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 606012
Contact: Dian Wang, MD, PhD    312-942-5751      
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Roberto Pili, MD    317-944-0920      
United States, Louisiana
Ochsner Cancer Institute Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Marc Matrana, MD    504-842-3910      
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Arif Hussain, MD    410-328-7225      
United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Kriti Mittal, MD, MS    508-334-3550      
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Zachery Reichert, MD, PhD    734-764-3066      
United States, Nebraska
GU Research Network / Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Tony Romero    402-991-8468      
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Nicholas Vogelzang, MD    702-952-3400      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Morris, MD    646-422-4469      
MD Anderson Cancer Center at Cooper Recruiting
Camden, New Jersey, United States, 08103
Contact: Ashish Patel, MD    855-632-2667      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Morris, MD    646-422-4469      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michael Morris, MD    646-422-4469      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Gurkamal Chatta, MD    716-845-2300      
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Michael Morris, MD    646-422-4469      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Michael Morris, MD    646-422-4469      
Northwell Health Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Thomas Bradley, MD    516-734-8894      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Morris, MD    646-422-4469      
Contact: Josef Fox, MD    212-639-7371      
Principal Investigator: Michael Morris, MD         
New York Presbyterian Hospital-Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Scott Tagawa, MD    646-962-2072      
Bronx VA Hospital Not yet recruiting
New York, New York, United States, 10468
Contact: Antonio Foio, MD, PhD    718-584-9000 ext 6669      
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Chunkit Fung, MD    585-275-5823      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Michael Morris, MD    646-422-4469      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Michael Morris, MD    646-422-4469      
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Young Whang, MD, PhD    984-974-0000      
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Abhishek Tripathi, MD    405-271-4088      
United States, Pennsylvania
MidLantic Urology Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Laurence Belkoff, DO    610-667-3020      
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Michael Lilly, MD    843-792-9300      
United States, Texas
Millennium Oncology Recruiting
Houston, Texas, United States, 77090
Contact: John Waldron, CCRP    877-870-2640    jwaldron@wmrad.com   
Millennium Physicians Recruiting
Houston, Texas, United States, 77090
Contact: Umang Patel, MD    281-440-5006      
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Celestia Higano, MD    855-557-0555      
Netherlands
Erasmus MC Cancer Institute Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Ronald de Wit, MD, PhD       r.dewit@erasmusmc.nl   
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bayer
Investigators
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Principal Investigator: Michael Morris, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03574571     History of Changes
Other Study ID Numbers: 18-150
2018-002944-10 ( EudraCT Number )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Radium-223
Docetaxel
18-150
C16-174
DORA Trial

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action