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NCT02981797

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

Completed Last updated 11 June 2021
What this trial tests

trial testing Blood Collection During Standard of Care Treatment in Prostate Cancer in 10 participants. Completed in 5 November 2020.

Timeline
22 July 2015
Primary endpoint
29 August 2017
5 November 2020

Quick facts

Lead sponsorH. Lee Moffitt Cancer Center and Research Institute
StatusCompleted
Study typeOBSERVATIONAL
Enrollment10
Start date22 July 2015
Primary completion29 August 2017
Estimated completion5 November 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, male only, with Prostate Cancer or Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Blood-Derived Biomarkers of Diagnosis, Prognosis and Therapy Response in Prostate Cancer Patients.
    Balázs K, Antal L, Sáfrány G, Lumniczky K. · · 2021 · cited 23× · PMID 33924671 · DOI 10.3390/jpm11040296

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Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other H. Lee Moffitt Cancer Center and Research Institute trials

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