Clinical trial · Interventional
Japanese BAY88-8223 Monotherapy Phase II Study
A Single-arm, Open-label, Multicenter, Phase II Study of BAY88-8223 in the Treatment of Japanese Patients With Symptomatic Castration-resistant Prostate Cancer (CRPC) With Bone Metastases
NCT01929655CI-TRIAL-00032652completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radium-223 dichloride
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Primary outcomes (1)
- measure
- Percentage of change in total alkaline phosphatase from baseline at 12 weeks
- timeFrame
- Baseline and 12 weeks
Secondary outcomes (13)
- measure
- Percentage of change in total alkaline phosphatase at the end of treatment
- timeFrame
- Baseline and 24 weeks
- measure
- Percentages of change in bone ALP at 12 weeks
- timeFrame
- Baseline and 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing. * Histologically or cytologically confirmed adenocarcinoma of the prostate * Multiple bone metastases * Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain. * Best standard of care(BSoC) is regarded as the routine standard of care. Exclusion Criteria : * Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period * History of visceral metastasis, or presence of visceral metastasis
References
Publications (1)
- DERIVEDMatsubara N, Nagamori S, Wakumoto Y, Uemura H, Kimura G, Yokomizo A, Kikukawa H, Mizokami A, Kosaka T, Masumori N, Kawasaki Y, Yonese J, Nasu Y, Fukasawa S, Sugiyama T, Kinuya S, Hosono M, Yamaguchi I, Tsutsui H, Uemura H. Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer. Int J Clin Oncol. 2018 Feb;23(1):173-180. doi: 10.1007/s10147-017-1176-0. Epub 2017 Aug 2. PMID 28770408