STAMPEDE2
Studying Treatments in patients receiving androgen deprivation therapy (ADT) and androgen receptor signalling inhibitors (ARSI) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2).
A randomised controlled platform trial testing treatments in metastatic hormone sensitive prostate cancer.
What is this study about?
STAMPEDE2 is a trial testing new treatments in men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer). It tests these treatments when the cancer is hormone-sensitive, which means that it is responsive to treatment with hormone therapy. STAMPEDE2 is a set of three randomised controlled trials (called comparisons) testing the addition of three new treatments to the standard-of-care.
- Treatment S: Stereotactic Ablative Body Radiotherapy (SABR), a type of radiotherapy.
- Treatment P: 177Lu-PSMA-617, a nuclear medicine therapy.
- Treatment N: Nira-AA+P, an oral drug therapy.
The primary objectives of each comparison are to test whether cancer outcomes can be improved by the addition of the research treatments to standard-of-care in men with metastatic prostate cancer and starting long-term androgen deprivation therapy.
Type of study
Randomised trial
Contact details
Data Sharing
We are following the data sharing policy of the MRC Clinical Trials Unit which follows a Data Release Request process for access to data once the primary results of the trial have been reported.
Who is funding the study?
The STAMPEDE2 Trial Platform is jointly funded by Cancer Research UK, Janssen Pharmaceutica NV and Novartis/AAA.
When is it taking place?
The trial is estimated to open within the first quarter of 2024.
Where is it taking place?
STAMPEDE2 takes place in participating hospitals within the UK. There are plans for international recruitment in the future.
Who is included?
Men at least 18 years of age with newly diagnosed or relapsed prostate cancer starting long-term hormone therapy and confirmed as metastatic using conventional CT and bone imaging, who meet the trial's eligibility criteria.
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