CAPItello-281
CAPItello-281 delivered the first AKT inhibitor success in prostate cancer, for the ~25% of men whose tumours have lost PTEN.
~1,000 men; rPFS significantly improved (topline Nov 2024, presented 2025); FDA approval Q2 2026. Diarrhoea, rash, hyperglycaemia as class effects.
- Median 40 vs 31.7 months with Capivasertib + abiraterone + ADT compared with Placebo + abiraterone + ADT; about 8.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 19 percent lower chance of the event at any given time (hazard ratio 0.81, likely range 0.68 to 0.96).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: De novo metastatic hormone-sensitive prostate cancer with PTEN deficiency: abiraterone + capivasertib vs abiraterone + placebo. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PTEN); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,012 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival, PTEN-deficient mHSPCprimary | Capivasertib + abiraterone + ADT | — | 40 months | 0.81 (0.68–0.96) | 0.017 | link |
| Placebo + abiraterone + ADT | — | 31.7 months |
Pages like this
not linked directly; found by shared links- PersonRamon E. Parsons
Shares AKT, PI3K / AKT / mTOR, Prostate cancer.
- TrialPROpel
Shares Abiraterone acetate, Prostate cancer.
- TrialCAPItello-291
Shares Capivasertib, AKT.
- PairingPI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6)
Shares Capivasertib, AKT, PI3K / AKT / mTOR.
- TrialMAGNITUDE
Shares Abiraterone acetate, Prostate cancer.
- PersonRobert A. Gatenby
Shares Abiraterone acetate, Prostate cancer.
- PersonPaul Workman
Shares Capivasertib, Abiraterone acetate.
- ProductGedatolisib
Shares AKT, PI3K / AKT / mTOR.