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NCT02981797
Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223
trial testing Blood Collection During Standard of Care Treatment in Prostate Cancer in 10 participants. Completed in 5 November 2020.
29 August 2017
Quick facts
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 22 July 2015 |
| Primary completion | 29 August 2017 |
| Estimated completion | 5 November 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blood Collection During Standard of Care Treatment
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
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):
-
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
Verify or expand the search:
- PubMed search for NCT02981797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02981797 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
- Last refreshed: 11 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02981797.
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