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STAMPEDE is the longest-running platform trial in oncology, and showed that both docetaxel and abiraterone extend life when started at first diagnosis of metastatic disease.
STAMPEDE opened in 2005 at the MRC Clinical Trials Unit at UCL, with Nicholas James as chief investigator and Mahesh Parmar as its statistician, as the first multi-arm multi-stage trial in cancer: several experimental arms recruited at once against one control arm of androgen deprivation therapy, each passing through interim activity stages before being allowed to continue to an overall survival comparison, with new arms added and failing arms dropped as the standard of care moved. Nearly 12,000 men with high-risk locally advanced or newly metastatic prostate cancer joined at more than 100 hospitals in the United Kingdom and Switzerland; Silke Gillessen led the Swiss contribution and later co-chaired the trial. The original arms added zoledronic acid, docetaxel, celecoxib and their combinations; the celecoxib arms were stopped for lack of activity in 2011, and abiraterone (2011), radiotherapy to the prostate (2013), abiraterone with enzalutamide (2014), metformin (2016) and transdermal oestradiol (run jointly with the PATCH trial) were added.
The results arrived in sequence and each changed practice. In 2016 the Lancet reported that docetaxel added to hormone therapy improved overall survival, most clearly in metastatic disease, while zoledronic acid added nothing; the finding replicated CHAARTED and made early chemotherapy a standard. In 2017 the New England Journal of Medicine reported, alongside LATITUDE, that abiraterone with prednisolone cut the risk of death by about a third (hazard ratio 0.63), which established abiraterone at first diagnosis of metastatic disease. In 2018 the Lancet reported that radiotherapy to the prostate improved survival in men with a low metastatic burden but not overall, and low-volume prostate radiotherapy entered guidelines. In 2022 the Lancet reported that two years of abiraterone improved metastasis-free and overall survival in high-risk non-metastatic disease, and that adding enzalutamide brought toxicity without benefit; the Lancet Oncology in 2023 confirmed the same for enzalutamide in metastatic disease. The metformin comparison, reported at ESMO in 2024 and since published, found no overall survival benefit from adding metformin for men starting hormone therapy for metastatic disease. The transdermal oestradiol comparison, run with PATCH, showed that oestrogen patches suppress testosterone as well as injections with fewer hot flushes, better bone health and no excess of cardiovascular events (Lancet 2021).
STAMPEDE is the proof that a single academic platform with a shared control arm can answer a decade of questions faster and more cheaply than separate trials, and its multi-arm multi-stage design is now used across cancer and beyond. Its weaknesses are the ones every platform inherits: the control arm changed as docetaxel and then abiraterone became standard, so later arms were compared with a moving baseline, and some comparisons (radiotherapy, enzalutamide) were read in subgroups defined after the fact. The successor, STAMPEDE2, opened in 2023 with comparisons of stereotactic radiotherapy to metastases, lutetium PSMA radioligand therapy and niraparib with abiraterone in men starting treatment for metastatic disease.
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.
11,992 enrolled.
6-year OS 60% · 6-year OS 45%
SourceNumbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, abiraterone arm (M1 subgroup)primary | ADT + abiraterone | - | 6-year OS 60% | 0.6 (0.5 to 0.71) | - | link |
| ADT alone | - | 6-year OS 45% | ||||
| Overall survival, docetaxel arm (M1) | ADT + docetaxel | - | 60 months | 0.76 | - | link |
| ADT alone | - | 45 months | ||||
| Overall survival, abiraterone comparison | Androgen deprivation with abiraterone and prednisolone | 960 | 184 deaths | 0.63 (0.52 to 0.76) | <0.001 | link |
| Androgen deprivation alone | 957 | 262 deaths | ||||
| Metastasis-free survival at 6 years, high-risk non-metastatic comparison | Androgen deprivation with 2 years of abiraterone | - | 82% | 0.53 (0.44 to 0.64) | <0.0001 | link |
| Androgen deprivation alone | - | 69% | ||||
| Overall survival, prostate radiotherapy comparison | Standard of care with prostate radiotherapy | 1,032 | - | 0.92 (0.8 to 1.06) | 0.266 | link |
| Standard of care | 1,029 | - | ||||
| Overall survival (median), metformin comparison | Standard of care with metformin | 936 | 67.4 months | 0.91 (0.8 to 1.03) | 0.15 | link |
| Standard of care | 938 | 61.8 months |
One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
A second publication from the STAMPEDE trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Two years of abiraterone with androgen deprivation and radiotherapy is the standard for very high-risk and node-positive localised prostate cancer.
One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
One trial page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT00268476 with the most citations, so it is the natural first reading for anyone following the STAMPEDE trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Mahesh K. B. Parmar, Silke Gillessen, Nicholas James, The Institute of Cancer Research.
Shares Interim analysis, readout and data cut-off, MRC Clinical Trials Unit at UCL, Seamless, adaptive and Bayesian trial designs, Master protocol (platform, basket and umbrella trials).
Shares Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial, Nicholas James, Zoledronic acid, Metastatic hormone-sensitive prostate cancer.
Shares Response-adaptive randomisation, Umbrella trial, Seamless, adaptive and Bayesian trial designs, Master protocol (platform, basket and umbrella trials).
Shares STAMPEDE: abiraterone with or without enzalutamide added to androgen deprivation for high-risk non-metastatic prostate cancer, Metastatic hormone-sensitive prostate cancer, Abiraterone acetate, Enzalutamide.
Shares GETUG-AFU 15, NRG Oncology RTOG 0521, STAMPEDE's arms, and what each one answered, PATCH (Prostate Adenocarcinoma Transcutaneous Hormone).
Shares CHAARTED (E3805), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors.
Shares PATCH (Prostate Adenocarcinoma Transcutaneous Hormone), CHAARTED (E3805), Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors.