Impact of Treatment Intensification with Abiraterone on Fracture-related Hospitalisation in Newly Diagnosed Prostate Cancer: A Secondary Analysis of Two Randomised Phase 3 Trials Within the STAMPEDE Trial Platform
In brief
Abiraterone cuts 5-year fracture-related hospitalisations by about a quarter in metastatic prostate cancer
In men with metastatic disease, adding abiraterone (with prednisolone, with or without enzalutamide) reduced the five-year rate of fracture-related hospital stays from roughly 30% to 22% (or 38% to 28%). The benefit was not seen in non-metastatic patients, and the analysis may miss fractures that did not require hospital care.
- Journal
- European urology (Q1)
- Published
- 8 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Struan Gray, Peter Dutey-Magni, Craig Jones, Laura R Murphy, Macey L Murray, Janet E Brown, et al.
- PMID
- 42711192
- DOI
- 10.1016/j.eururo.2026.08.012
Why clinicians should know about it
- Picked for Urology (top studies of the week, 13 September 2026): Abiraterone does not increase fracture‑related hospitalisation
Abstract
BACKGROUND: Prostate cancer (PCa) patients are at increased fracture risk due to the need for androgen deprivation therapy (ADT) and progressive bone metastases. Previous meta-analyses of randomised controlled trials suggest that androgen receptor pathway inhibitors (ARPIs) increase fracture risk. OBJECTIVE: We assessed the impact of abiraterone-based treatment intensification on fracture-related hospitalisation (FRH) within the STAMPEDE trial platform. DESIGN, SETTING AND PARTICIPANTS: We performed a secondary analysis of two STAMPEDE trials in patients with high-risk non-metastatic (M0) or metastatic (M1) disease. INTERVENTIONS: Patients were allocated to either standard of care (SOC) or SOC plus abiraterone with prednisolone (AAP) or, in a later comparison, SOC+AAP with enzalutamide (Enza). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A prespecified coding framework within Hospital Episode Statistics (HES) identified FRHs. Flexible parametric competing-risk models estimated 5-year cumulative incidence of FRH and sub-distribution hazard ratios (SDHR), with death as a competing risk. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Between Nov 2011 and Mar 2016, 3893 patients were randomised to the STAMPEDE AAP±Enza trials. Linked HES data were available for 3102 patients in England. In M1 disease, 5-year FRH incidence was significantly lower with SOC + AAP than SOC alone (22% vs 30%; SDHR 0.77, 95%CI 0.59-0.99; p = 0.04) and with SOC + AAP + Enza than SOC alone (28% vs 38%; SDHR 0.69, 95%CI 0.54-0.88; p = 0.002). No significant difference was observed in M0 patients. Limitations include potential under-estimation of total fracture burden by exclusion of non-hospitalised fractures, lack of baseline assessment of fracture risk including bone mineral density, and longitudinal use of bone-protective therapy. CONCLUSIONS: Abiraterone-based treatment intensification did not increase FRH compared to SOC alone. In M1 disease, abiraterone reduced rather than augmented fracture risk, most plausibly reflecting improved metastatic bone disease control.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.