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The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03368989
Collaborator
(none)
21
Enrollment
1
Location
35.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.

Condition or Disease Intervention/Treatment Phase
  • Drug: Radium-223 dichloride

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
Actual Study Start Date :
Feb 11, 2014
Actual Primary Completion Date :
Feb 7, 2017
Actual Study Completion Date :
Feb 7, 2017

Arms and Interventions

Arm Intervention/Treatment
treatment with radium-223 Dichloride (Xofigo)

Drug: Radium-223 dichloride
Previously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells.
Other Names:
  • Xofigo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in number of osteoblastic bone lesions [Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)]

      number of lesions specified before and after the treatment with a bone scan

    Secondary Outcome Measures

    1. functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale [Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments]

      The ECOG scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The possible scores on the scale are 0 to 5, with 0 being the best outcome and 5 being the worst outcome, details of each score are listed below. Grade 0 = Fully active, able to carry on all pre-disease performance without restriction Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5 = Dead

    2. pain level as assessed by numeric rating score [Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments]

      As assessed using numeric rating score from 1-10 with 10 being the highest level of pain

    3. (PSA) prostate specific antigen level [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      normal level should be 4.0 ng/mL. value is measured after each dose

    4. (ALP) alkaline phosphatase level [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      The normal value for alkaline phosphatase is 53 to 128 U/L.

    5. Hemoglobin level [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      The normal level for males is 14 to 18 g/dl

    6. Platelet level [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      A normal platelet count ranges from 150,000 to 450,000 platelets

    7. Neutrophil count [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      The normal range for neutrophils is 2.5-7.5 x 10 9 /L

    8. Creatinine level [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL)

    9. white blood cell count [pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments]

      The typical white blood cell count varies from 4,000 to 10,000 cells per mm3.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Prostate cancer patients scheduled for treatment with Radium-223.
    Exclusion Criteria:
    • Patients not completing their treatment regimen for any reason

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

    • Principal Investigator: Isis W Gayed, MD, The University of Texas Health Science Center, Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isis W Gayed, Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT03368989
    Other Study ID Numbers:
    • HSC-MS-14-0113
    First Posted:
    Dec 11, 2017
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Neoplasm Metastasis
    Radium Ra 223 dichloride

    Study Results

    No Results Posted as of Jun 11, 2019