Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017
An exploratory analysis of alkaline phosphatase, lactate dehydrogenase, and prostate-specific antigen dynamics in the phase 3 ALSYMPCA trial with radium-223.
Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
87 citing papers in PubMed, 1 synthesis or guideline pooled it, 167 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
- Alkaline phosphatase decline and pain response as predictors of overall survival benefit in patients treated with radium-223: a post hoc analysis of the REASSURE study.British journal of cancer · 2025Trial
- A phase II randomized trial of metastasis-directed therapy with alpha emitter radium-223 in men with oligometastatic castration-resistant prostate cancer (MEDAL).BMC urology · 2023Trial
- 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
- Patterns of Cancer Progression of Metastatic Hormone-sensitive Prostate Cancer in the ECOG3805 CHAARTED Trial.European urology oncology · 2020Trial
- Prospective Evaluation of Bone Metabolic Markers as Surrogate Markers of Response to Radium-223 Therapy in Metastatic Castration-resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Trial
- Trial
- 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
- Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program.BMC cancer · 2019Trial
- Pharmacodynamic study of radium-223 in men with bone metastatic castration resistant prostate cancer.PloS one · 2019Trial
- Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer.International journal of clinical oncology · 2018Trial
- Re-treatment with radium-223: first experience from an international, open-label, phase I/II study in patients with castration-resistant prostate cancer and bone metastases.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- Physiological elasticity and topography modulateiScience · 2026Article
- Spatial immune profiling of bone-metastatic castration-resistant prostate cancer reveals radium-223 immunomodulates the bone-tumor microenvironment.Prostate cancer and prostatic diseases · 2026Article
- Bone marrow scintigraphy as a prognostic marker of overall survival in mCRPC patients treated with Radium-223 dichloride.European journal of nuclear medicine and molecular imaging · 2026Article
- Radium-223 use and survival by line of treatment in metastatic castration-resistant prostate cancer: a nationwide population-based register study.Acta oncologica (Stockholm, Sweden) · 2025Article
- Prognostic value of whole-body diffusion-weighted imaging with background body signal suppression in CRPC patients undergoing Ra-223 therapy: an exploratory analysis.Japanese journal of radiology · 2025Article
- 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
- Treatment outcomes with radium-223 in patients with metastatic castration-resistant prostate cancer with bone metastasis in real-world practice: a multiinstitutional study.Prostate international · 2025Article
- Prognostic Value of Automated Bone Scan Index (aBSI) in Patients with mCRPC Undergoing Three vs. Six Cycles ofDiagnostics (Basel, Switzerland) · 2025Article
27 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Baseline clinical variables are prognostic for overall survival (OS) in patients with castration-resistant prostate cancer (CRPC). Their prognostic and predictive value with agents targeting bone metastases, such as radium-223, is not established. Patients and methods: The radium-223 ALSYMPCA trial enrolled patients with CRPC and symptomatic bone metastases. Prognostic potential of baseline variables was assessed using Cox models. Percentage changes in biomarker levels from baseline were evaluated during the trial period; changes from baseline to week 12 were evaluated for association with OS and surrogacy. Results: Eastern Cooperative Oncology Group performance status, total alkaline phosphatase (tALP), lactate dehydrogenase (LDH), and prostate-specific antigen (PSA) at baseline were associated with OS (P ≤ 0.0003) in the intent-to-treat population (radium-223, N = 614; placebo, N = 307). tALP declined from baseline within 4 weeks after beginning radium-223, by week 12 declining in 87% of radium-223 and 23% of placebo patients (P < 0.001). LDH declined in 51% and 34% (P = 0.003), whereas PSA declined in 27% and 14% (P = 0.160). Mean tALP change from baseline was 32.2% decrease with radium-223 and 37.2% increase with placebo. Radium-223 patients with tALP decline from baseline to week 12 (confirmed ≥3 weeks from week 12) had 55% lower risk of death (hazard ratio = 0.45; 95% CI 0.34-0.61) versus those with no confirmed tALP decline. Proportional treatment effect (PTE) values for tALP, LDH, and PSA changes from baseline at week 12 as OS surrogate markers were 0.34 (95% CI: 0-0.746), 0.07 (95% CI: 0-0.211), and 0 (95% CI: 0-0.082), respectively. Conclusions: Significant tALP declines (versus placebo) occurred as early as 4 weeks after beginning radium-223 therapy. tALP or LDH declines at 12 weeks correlated with longer OS, but did not meet statistical surrogacy requirements. Dynamic changes in tALP and LDH during radium-223 treatments may be useful to monitor, but do not serve as surrogates for survival.
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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.