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

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ClinicalTrials.gov Identifier: NCT03368989
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Isis W Gayed, The University of Texas Health Science Center, Houston

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
Bony Metastases From Castrate Refractory Prostate Cancer Drug: Radium-223 dichloride

Study Type : Observational
Estimated Enrollment : 40 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 : February 11, 2014
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Group/Cohort 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 Name: Xofigo



Primary Outcome Measures :
  1. Change in number of osteoblastic bone lesions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males presenting with prostate cancer.
Criteria

Inclusion Criteria:

  • Prostate cancer patients scheduled for treatment with Radium-223.

Exclusion Criteria:

  • Patients not completing their treatment regimen for any reason

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): NCT03368989


Contacts
Contact: Isis W Gayed, MD 713-704-1789 isis.w.gayed@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Isis W Gayed, MD    713-704-1789    isis.w.gayed@uth.tmc.edu   
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

Responsible Party: Isis W Gayed, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03368989     History of Changes
Other Study ID Numbers: HSC-MS-14-0113
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

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:
Radium Ra 223 dichloride
Antineoplastic Agents