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Completed

NCT Number: NCT03368989

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients not completing their treatment regimen for any reason

Treatment and study plan

Radium-223 dichloride

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2017
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.