Trial reportInternational journal of clinical oncology2018
Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer.
Trial report in International journal of clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01929655 (A Single-arm, Open-label, Multicenter, Phase II Study of BAY88-8223 in the Treatment of Japanese Patients With Symptomatic Castration-resistant Prostate Cancer), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Radium-223 dichloride in prostate cancer: proof of principle for the use of targeted alpha treatment in clinical practice.European journal of nuclear medicine and molecular imaging · 2020Pooled it
- Radium-223 in Asian patients with castration-resistant prostate cancer with symptomatic bone metastases: A single-arm phase 3 study.Asia-Pacific journal of clinical oncology · 2021Trial
- A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study.International journal of clinical oncology · 2020Trial
- Three-year follow-up of a phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer and bone metastases.International journal of clinical oncology · 2019Trial
- Real-World Outcomes of Radium-223 Therapy in Metastatic Castration-Resistant Prostate Cancer: Predictive Value of PSA Doubling Time and Enzalutamide Continuation.International journal of urology : official journal of the Japanese Urological Association · 2026Article
- 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.International journal of clinical oncology · 2025Article
- Investigation of the safety of Radium-223 chloride in combination with external beam radiotherapy for bone metastases of prostate cancer.Journal of radiation research · 2025Article
- Evaluation of two-dimensional total bone uptake (2D-TBU) and bone scan index (BSI) extracted from active bone metastatic burden on the bone scintigraphy in patients with radium-223 treatment.Annals of nuclear medicine · 2024Article
- Treatment outcomes of radium-223 in patients with metastatic castration-resistant prostate cancer: An experience before National Health Insurance reimbursement in Taiwan.Journal of the Chinese Medical Association : JCMA · 2023Article
- Clinical outcomes and treatment patterns in REASSURE: planned interim analysis of a real-world observational study of radium-223 in metastatic castration-resistant prostate cancer.EClinicalMedicine · 2023Article
- Clinical significance of completion of radium-223 treatment and acute adverse events in patients with metastatic castration-resistant prostate cancer.Asia Oceania journal of nuclear medicine & biology · 2023Article
- Administration of radium-223 and the prognosis in Japanese bone metastatic castration-resistant prostate cancer patients: A large database study.International journal of urology : official journal of the Japanese Urological Association · 2022Article
- Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review.Therapeutic advances in medical oncology · 2022Review
- Interim and end-treatmentScientific reports · 2021Article
- 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 concomitant use of second-generation androgen-receptor axis-targeted agents.International journal of clinical oncology · 2021Article
- Dynamic changes of bone metastasis predict bone-predominant status to benefit from radium-223 dichloride for patients with castration-resistant prostate cancer.Cancer medicine · 2020Article
- Bone scan index can be a useful biomarker of survival outcomes in patients with metastatic castration-resistant prostate cancer treated with radium-223.Cancer reports (Hoboken, N.J.) · 2019Article
- Introduction of the targeted alpha therapy (with Radium-223) into clinical practice in Japan: learnings and implementation.Annals of nuclear medicine · 2019Article
- Appropriate Patient Status for Ra-223 Treatment in the Treatment Sequence for Castration-resistant Prostate Cancer.Cancer diagnosis & prognosisArticle
- Risk Scoring System for Ra-223 Discontinuation and Its Effect on Prognosis: A Retrospective Study.Cancer diagnosis & prognosisArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 18 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRadium-223 dichloride (radium-223) is the first targeted alpha therapy approved for the treatment of castration-resistant prostate cancer (CRPC) with bone metastases. This study investigated the efficacy and safety of radium-223 in Japanese patients with symptomatic CRPC and bone metastases.
methodsIn this open-label, multicenter, phase II study, patients with progressive, symptomatic CRPC and bone metastases were treated with radium-223 (55 kBq/kg, intravenously) in a 4-week cycle for six cycles. The primary endpoint was the percent change in total alkaline phosphatase (ALP) from baseline at 12 weeks. Secondary endpoints included the percent ALP change from baseline to end of treatment (EOT), ALP response rates, percent change in prostate-specific antigen (PSA) from baseline to 12 weeks and EOT, PSA response rates, overall survival (OS), and time to symptomatic skeletal events (SSEs). Adverse events were monitored throughout the study period.
resultsOf the 49 Japanese patients (median age 74 years), 28 completed all infusions. Mean percent change in total ALP and PSA from baseline to 12 weeks was -19.3 and +97.4%, respectively. One-year OS and SSE-free rate at the end of active follow-up were 78 and 89%, respectively. The ALP response rate was 31%, while the PSA response rate was 6%. Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients included decreased lymphocyte count (14%), anemia (14%), anorexia (10%), and bone pain (10%).
conclusionsRadium-223 is effective and well tolerated in Japanese patients with CRPC and bone metastases. Results were comparable with the Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. CLINICAL
trial registrationClinicalTrials.gov NCT01929655.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.