STAMPEDE
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy
Phase 2/3N = 1,917NCT00268476
- Population
- Men starting long-term ADT with locally advanced or metastatic prostate cancer (52% metastatic; 95% newly diagnosed)
- Design
- Comparison within the STAMPEDE platform (also registered as ISRCTN78818544): 1:1 randomization to ADT alone or ADT plus abiraterone acetate 1000 mg and prednisolone 5 mg daily; open-label per the 2023 final report. Local radiotherapy was mandated for node-negative non-metastatic disease and encouraged for node-positive disease. Primary outcome overall survival; intermediate primary outcome failure-free survival. Randomization November 2011 to January 2014.
- Primary endpoint
- OS
- Arms
- ADT alone (control): Androgen-deprivation therapy alone (2017 report); in the 2023 report the standard-of-care control could include docetaxel with prednisolone from 17 December 2015
- ADT plus abiraterone acetate and prednisolone (experimental): ADT plus abiraterone acetate 1000 mg and prednisolone 5 mg daily
- People
- James ND, STAMPEDE Investigators
OSHR 0.63 (95% CI 0.52–0.76)FFSHR 0.29 (95% CI 0.25–0.34)OSHR 0.62 (95% CI 0.53–0.73)Δ median OS+30.9 months
Show the numbers
| Endpoint | Analysis | ADT plus abiraterone acetate and prednisolone | ADT alone | Effect |
|---|---|---|---|---|
| OSRandomized patients, all stages (analysis population not stated in the abstract) | primarymedian follow-up 40 monthsJames 2017 | — | — | HR 0.63 (95% CI 0.52–0.76)P<0.001184 deaths in the combination group and 262 in the ADT-alone group. The hazard ratio was 0.75 in non-metastatic and 0.61 in metastatic disease. |
| FFSRandomized patients, all stages (analysis population not stated in the abstract) | primarymedian follow-up 40 monthsJames 2017 | — | — | HR 0.29 (95% CI 0.25–0.34)P<0.001Treatment failure was defined as radiologic, clinical or PSA progression, or death from prostate cancer. 248 events in the combination group and 535 in the ADT-alone group. The hazard ratio was 0.21 in non-metastatic and 0.31 in metastatic disease. |
| OSMetastatic disease only: 1003 patients (501 abiraterone, 502 standard of care) in the 'abiraterone trial' of the 2023 report | finalmedian follow-up 96 monthsAttard 2023 | median 76.6 months (67.8–86.9) | median 45.7 months (41.6–52.0) | HR 0.62 (95% CI 0.53–0.73)P<0.0001Open-label comparison in metastatic disease only; the standard-of-care group could receive docetaxel with prednisolone from 17 December 2015. This population differs from the all-stage 2017 analysis. |
| Endpoint | Analysis | ADT plus abiraterone acetate and prednisolone | ADT alone | Effect |
|---|---|---|---|---|
| OSRandomized patients, all stages (analysis population not stated in the abstract) | primarymedian follow-up 40 monthsJames 2017 | — | — | HR 0.63 (95% CI 0.52–0.76)P<0.001184 deaths in the combination group and 262 in the ADT-alone group. The hazard ratio was 0.75 in non-metastatic and 0.61 in metastatic disease. |
| FFSRandomized patients, all stages (analysis population not stated in the abstract) | primarymedian follow-up 40 monthsJames 2017 | — | — | HR 0.29 (95% CI 0.25–0.34)P<0.001Treatment failure was defined as radiologic, clinical or PSA progression, or death from prostate cancer. 248 events in the combination group and 535 in the ADT-alone group. The hazard ratio was 0.21 in non-metastatic and 0.31 in metastatic disease. |
| OSMetastatic disease only: 1003 patients (501 abiraterone, 502 standard of care) in the 'abiraterone trial' of the 2023 report | finalmedian follow-up 96 monthsAttard 2023 | median 76.6 months (67.8–86.9) | median 45.7 months (41.6–52.0) | HR 0.62 (95% CI 0.53–0.73)P<0.0001Open-label comparison in metastatic disease only; the standard-of-care group could receive docetaxel with prednisolone from 17 December 2015. This population differs from the all-stage 2017 analysis. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.63 | 0.52–0.76 |
| FFS | 0.29 | 0.25–0.34 |
| OS | 0.62 | 0.53–0.73 |
- ADT alone (control)
- ADT plus abiraterone acetate and prednisolone (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | ADT alone | ADT plus abiraterone acetate and prednisolone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 48 | 48.3% | 64.8% |
| 96 | 23.3% | 41.9% |
| 144 | 11.3% | 27.2% |
| 192 | 5.4% | 17.6% |
Appears in
Sources
James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, et al. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017;377(4):338-351.
Attard G, Murphy L, Clarke NW, Sachdeva A, Jones C, Hoyle A, et al. Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. Lancet Oncol. 2023;24(5):443-456.