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NCT02803437
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
trial testing Radium-223 dichloride (Xofigo, BAY 88-8223) in Prostatic Neoplasms, Castration-Resistant in 334 participants. Completed in 18 December 2024.
6 January 2022
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 334 |
| Start date | 21 July 2016 |
| Primary completion | 6 January 2022 |
| Estimated completion | 18 December 2024 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Radium-223 dichloride (Xofigo, BAY 88-8223) — full drug profile →
Conditions studied
- Prostatic Neoplasms, Castration-Resistant — all drugs for Prostatic Neoplasms, Castration-Resistant →
Sponsor
Bayer — full company profile →
Who can join
Eligibility, male only, with Prostatic Neoplasms, Castration-Resistant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Radium 223 dichloride for prostate cancer treatment.
Deshayes E, Roumiguie M, Thibault C, Beuzeboc P, et al · · 2017 · cited 65× · PMID 28919714 · DOI 10.2147/dddt.s122417 -
Real-world safety and effectiveness of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastasis: exploratory analysis, based on the results of post-marketing surveillance, according to prior chemotherapy status and in patients without c
Uemura H, Masumori N, Takahashi S, Hosono M, et al · · 2021 · cited 14× · PMID 33575828 · DOI 10.1007/s10147-020-01850-3 -
Post-marketing surveillance of radium-223 chloride in Japanese patients with castration-resistant prostate cancer with bone metastasis-final analysis of 3-year extended follow-up focusing on bone fractures.
Masumori N, Hosono M, Takahashi S, Kakehi Y, et al · · 2025 · cited 2× · PMID 40779218 · DOI 10.1007/s10147-025-02846-7
Verify or expand the search:
- PubMed search for NCT02803437
- 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, BAY 88-8223)
Trials testing the same drug.
- NCT03996473 — Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination · Phase 1 · terminated
Other recruiting trials for Prostatic Neoplasms, Castration-Resistant
Currently open trials in the same condition.
- NCT07225946 — A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Canc · Phase 3 · recruiting
- NCT06706921 — 18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer · Phase 4 · recruiting
- NCT06353386 — Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Particip · Phase 1, PHASE2 · recruiting
- NCT05743621 — Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer · Phase 1 · recruiting
- NCT05393791 — Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC · Phase 2 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02803437 (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: 10 July 2025
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/NCT02803437.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing