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NCT01810770
Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis
Completed
Phase 3
Last updated 19 September 2018
What this trial tests
Phase 3 trial testing Radium-223 dichloride (Xofigo, BAY88-8223) in Prostatic Neoplasms in 243 participants. Completed in 25 September 2017.
Timeline
26 March 2013
Primary endpoint
25 September 2017
25 September 2017
25 September 2017
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 243 |
| Start date | 26 March 2013 |
| Primary completion | 25 September 2017 |
| Estimated completion | 25 September 2017 |
| Sites | 27 locations across China, Taiwan, Singapore, South Korea |
Drugs / interventions tested
- Radium-223 dichloride (Xofigo, BAY88-8223) — full drug profile →
Conditions studied
- Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
Sponsor
Bayer — full company profile →
Who can join
18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and efficacy (Overall survival \[OS\]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting signaling pathways in prostate cancer: mechanisms and clinical trials.
He Y, Xu W, Xiao YT, Huang H, et al · · 2022 · cited 192× · PMID 35750683 · DOI 10.1038/s41392-022-01042-7 -
Radionuclide Therapies in Prostate Cancer: Integrating Radium-223 in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer.
Nilsson S. · · 2016 · cited 27× · PMID 26779616 · DOI 10.1007/s11912-015-0495-4 -
Targeting Bone Metastases in Metastatic Castration-Resistant Prostate Cancer.
El-Amm J, Aragon-Ching JB. · · 2016 · cited 25× · PMID 27042152 · DOI 10.4137/cmo.s30751 -
Radium-223 in Asian patients with castration-resistant prostate cancer with symptomatic bone metastases: A single-arm phase 3 study.
Zhou T, Zhou F, Guo J, Shi H, et al · · 2021 · cited 8× · PMID 33051982 · DOI 10.1111/ajco.13479 -
Advances in the treatment of metastatic prostate cancer in China.
Wang B, Liu Z, Yang L, Zhang X. · · 2025 · cited 1× · PMID 40387589 · DOI 10.20892/j.issn.2095-3941.2025.0065
Verify or expand the search:
- PubMed search for NCT01810770
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Radium-223 dichloride (Xofigo, BAY88-8223)
Trials testing the same drug.
- NCT05301062 — A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Ad · terminated
- NCT04521361 — A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones · Phase 1 · completed
- NCT04597125 — RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhi · Phase 4 · active not recruiting
- NCT04516161 — EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Sur · completed
- NCT04232761 — Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, W · completed
Other recruiting trials for Prostatic Neoplasms
Currently open trials in the same condition.
- NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
- NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
- NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
- NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
- NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01810770 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Bayer
- Last refreshed: 19 September 2018
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/NCT01810770.
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