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

NCT03368989 | Completed FDA Drug

• 1 other identifier: HSC-MS-14-0113
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bony Metastases From Castrate Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• pain level as assessed by numeric rating score

  Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments

• (PSA) prostate specific antigen level

  pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments

• (ALP) alkaline phosphatase level

  pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments

• Hemoglobin level

  pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments

Study Arms (1)

treatment with radium-223 Dichloride (Xofigo)

Drug: Radium-223 dichloride

Interventions

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.

Also known as: Xofigo

treatment with radium-223 Dichloride (Xofigo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males presenting with prostate cancer.

You may qualify if:

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

You may not qualify if:

• Patients not completing their treatment regimen for any reason

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

radium Ra 223 dichloride

Study Officials

• Isis W Gayed, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: December 11, 2017
• Study Start: February 11, 2014
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)