ReachRxResearch
Home
Research
Sign Up
  1. Home
  2. Research Hub
  3. Impact of Treatment Intensification with…

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

European Urology·September 8Open Access
Urology & NephrologyPractice changingBone MetastasesFractureProstate CancerSecondary Analysis Of Randomised Controlled TrialsAndrogen Deprivation TherapyAndrogen Receptor Pathway InhibitorAdultXtandiZytigaAbirateroneEnzalutamidePrednisolone

Summary

View source

What was studied

This secondary analysis of two STAMPEDE phase 3 trials evaluated whether abiraterone-based treatment intensification (SOC+AAP ± enzalutamide) increased fracture-related hospitalisation (FRH) compared to standard of care (SOC) alone in 3,102 patients with newly diagnosed high-risk non-metastatic (M0) or metastatic (M1) prostate cancer in England, with up to 5-year follow-up.

Key findings

In M1 disease, 5-year FRH incidence was **lower** with SOC+AAP vs. SOC alone (22% vs. 30%; SDHR 0.77, 95% CI 0.59–0.99; p=0.04), and lower still with SOC+AAP+Enza vs. SOC alone (28% vs. 38%; SDHR 0.69, 95% CI 0.54–0.88; p=0.002); no significant difference was seen in M0 patients.

Study limitations

- Only hospitalised fractures were captured, likely **underestimating** total fracture burden. - No baseline bone mineral density or fracture-risk assessment was available. - Longitudinal bone-protective therapy use was not systematically recorded, which may confound results.

Clinical implications

Clinicians can reassure patients with metastatic prostate cancer that abiraterone-based intensification does not increase — and may actually reduce — fracture-related hospitalisation, likely through better control of bone metastases. Bone-protective strategies remain important, but ARPI-related fracture risk concerns should not deter treatment intensification in M1 disease.

Caveats

  • Brand names (Zytiga, Xtandi) inferred from generic drug names; not explicitly stated in the abstract.
  • FRH data were derived from Hospital Episode Statistics (HES) in England only, limiting generalisability to other healthcare systems.
  • Study design is a secondary analysis; causal inference is limited by residual confounding (e.g., unrecorded bone-protective therapy use).
Show all 4
  • The impact_flag 'practice_changing' is applied because this finding directly counters prior meta-analytic signals suggesting ARPIs increase fracture risk, but it is based on a secondary analysis rather than a primary pre-specified endpoint.

Related Questions

Explore related topics

Does abiraterone increase fracture risk in metastatic prostate cancer?Bone-protective therapy use during androgen deprivation therapy for prostate cancerSTAMPEDE trial outcomes for high-risk non-metastatic prostate cancer

Publication Details

Year
2026
Journal
European Urology
Sample Size
n=3,102
Source
View article
Keep scrolling
More content below.
Up Next