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Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223

NCT02981797 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-06-11

No results posted yet for this study

Summary

This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as standard of care.

Participants will take part in this research study because they have chosen Radium 223 treatment for their prostate cancer that has spread to the bone and causing pain. Investigators want to find out if a blood test performed before and after the Radium 223 treatment will help to understand how prostate cancer cells react to this therapy.

In this pilot study, researchers want to find out if Radium 223 given as part of standard treatment for prostate cancer can decrease the number of circulating prostate cancer cells. Radium 223 kills prostate cancer cells by damaging their DNA. Other than looking at the changes in the number of circulating prostate cancer cells before and after Radium 223, researchers would also like to look at the changes in a DNA damage marker, called gamma H2AX, in the circulating prostate cancer cells before and after treatment with Radium 223. Assessing the DNA damage marker gamma H2AX is investigational. It is performed in the same tube of blood that is used for assessing the changes in the number of circulating prostate cancer cells.

Conditions

Interventions

OTHER

Blood Collection During Standard of Care Treatment

Blood collection for baseline CTC numeration and H2AX assay. Circulating prostate cancer cell analysis requires blood draw of 7.5 ml (about 1 ½ teaspoons) of blood, to be performed at the screening, 1-2 hours before the third and sixth dose of radium 223 and 24 hours after the first, third, sixth dose of Radium 223. Standard of care Radium 223 treatment is given every 4 weeks for a total of 6 treatments and post Radium 223 follow up at week 24 is also considered standard of care. Other than these standard clinic visits and treatments, the study only requires 3 extra trips to the cancer center for blood draw at 24 hours after the first, third, sixth dose of Radium 223. Blood draws other than circulating tumor cell analysis is considered standard of care and doesn't require extra visits.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jingsong Zhang, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-22
Primary Completion
2017-08-29
Completion
2020-11-05

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981797 on ClinicalTrials.gov