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CAPItello-281

Capivasertib plus abiraterone versus placebo plus abiraterone in de novo metastatic hormone-sensitive prostate cancer characterised by PTEN deficiency

Phase 3N = 1,012NCT04493853

Population
De novo metastatic hormone-sensitive prostate cancer with PTEN-deficient tumours (the registry title and the FDA letter say de novo; the FDA notice says newly diagnosed); 25.3% (1519 of 6003) of patients with valid tumour test results were PTEN-deficient
Design
Double-blind, randomised (1:1) phase 3 trial of capivasertib or placebo plus abiraterone, prednisone or prednisolone, and androgen deprivation therapy. PTEN deficiency was defined as at least 90% of viable malignant cells with no specific cytoplasmic PTEN immunohistochemistry staining. The primary endpoint was investigator-assessed radiographic progression-free survival; overall survival was a key secondary endpoint.
Primary endpoint
rPFS
Arms
  • Capivasertib plus abiraterone (experimental, n = 507): Capivasertib plus abiraterone, prednisone or prednisolone, and ADT
  • Placebo plus abiraterone (control, n = 505): Placebo plus abiraterone, prednisone or prednisolone, and ADT
People
Fizazi K
rPFSHR 0.81 (95% CI 0.66–0.98)Δ median rPFS+7.5 monthsOSHR 0.90 (95% CI 0.71–1.15)
Show the numbers
Results reported for CAPItello-281
EndpointAnalysisCapivasertib plus abirateronePlacebo plus abirateroneEffect
rPFSRandomised PTEN-deficient population (n=1012)Investigator-assessed radiographic progression-free survivalprimaryFizazi 2026median 33.2 monthsmedian 25.7 monthsHR 0.81 (95% CI 0.66–0.98)P=0.034
OSOverall population studied (PTEN-deficient)interimFizazi 2026——HR 0.90 (95% CI 0.71–1.15)P=0.401Overall survival at 26.4% maturity.
Results reported for CAPItello-281
EndpointAnalysisCapivasertib plus abirateronePlacebo plus abirateroneEffect
rPFSRandomised PTEN-deficient population (n=1012)Investigator-assessed radiographic progression-free survivalprimaryFizazi 2026median 33.2 monthsmedian 25.7 monthsHR 0.81 (95% CI 0.66–0.98)P=0.034
OSOverall population studied (PTEN-deficient)interimFizazi 2026——HR 0.90 (95% CI 0.71–1.15)P=0.401Overall survival at 26.4% maturity.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
rPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
rPFS0.810.66–0.98
OS0.90.71–1.15
Illustrative — modelled from reported values, not trial data. rPFS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Capivasertib plus abiraterone (experimental)
  • Placebo plus abiraterone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCapivasertib plus abirateronePlacebo plus abiraterone
0100.0%100.0%
2164.5%56.8%
4241.6%32.2%
6227.4%18.8%
8317.7%10.7%
Primary publication: Fizazi K, Clarke NW, De Santis M, Uemura H, Fay AP, Karadurmus N, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68. PubMedDOI

Appears in

Sources

  1. Fizazi K, Clarke NW, De Santis M, Uemura H, Fay AP, Karadurmus N, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol. 2026;37(1):53-68.

    PubMedDOI