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.

Study Overview

• Status: Completed
• Conditions: Bony Metastases From Castrate Refractory Prostate Cancer
• Intervention / Treatment: Drug: Radium-223 dichloride

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Males presenting with prostate cancer.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not completing their treatment regimen for any reason

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Xofigo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of osteoblastic bone lesions	number of lesions specified before and after the treatment with a bone scan	Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale	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	Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
pain level as assessed by numeric rating score	As assessed using numeric rating score from 1-10 with 10 being the highest level of pain	Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
(PSA) prostate specific antigen level	normal level should be 4.0 ng/mL. value is measured after each dose	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
(ALP) alkaline phosphatase level	The normal value for alkaline phosphatase is 53 to 128 U/L.	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Hemoglobin level	The normal level for males is 14 to 18 g/dl	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Platelet level	A normal platelet count ranges from 150,000 to 450,000 platelets	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Neutrophil count	The normal range for neutrophils is 2.5-7.5 x 10 9 /L	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Creatinine level	Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL)	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
white blood cell count	The typical white blood cell count varies from 4,000 to 10,000 cells per mm3.	pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2014
• Primary Completion (Actual): February 7, 2017
• Study Completion (Actual): February 7, 2017

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Prostatic Neoplasms; Neoplasm Metastasis; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: HSC-MS-14-0113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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