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STAMPEDE 2: A randomised controlled platform trial testing treatments in metastatic hormone sensitive prostate cancer

 

STAMPEDE2 is a clinical 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 at a stage where it is responsive to treatment with hormone therapy.

It is a separate trial from the previous STAMPEDE trial which initiated 10 comparisons in high-risk, non-metastatic and metastatic prostate cancer between 2005 and 2017. The STAMPEDE trial has now completed recruitment, the final day of patient randomisation being completed on 31st March 2023. For more information about the STAMPEDE trial visit: STAMPEDE Trial Website.

STAMPEDE2 is a set of randomised controlled trials (called comparisons) testing the addition of new treatments to standard of care (SoC) treatment:

  • Comparison S: testing the addition of Stereotactic Ablative Body Radiotherapy (SABR): a type of radiotherapy.
  • Comparison P: testing the addition of 177Lu-PSMA-617 (called PSMA-Lutetium): a nuclear medicine therapy.

For more information on the above treatments, visit: About STAMPEDE2.

The primary objective of each comparison is to test:

  • Whether survival can be improved by the addition of the research treatments to SoC in men with metastatic prostate cancer and starting long-term androgen deprivation therapy.

The key secondary objectives of each comparison are to test:

  • Whether addition of the research treatments extends the time it takes for the cancer to get worse.
  • The toxicity and compliance with the research arms.
  • Whether Quality of Life is altered with the addition of research therapies.
  • Cost and resource use including EQ-5D-5L to calculate the incremental cost-effectiveness ratio of comparisons, or the net monetary benefits by arm, as appropriate.

STAMPEDE2 aims to measure the following primary and secondary outcomes:

  • Primary Outcome Measure: Overall Survival (OS).
  • Secondary Outcome Measures: Radiographic Progression-Free-Survival (ePFS), Failure-Free Survival (FFS), Prostate cancer specific survival (PCSS), safety, toxicity, compliance, cost and resources.

STAMPEDE2 is sponsored by University College London and is funded by Cancer Research UK for Comparison S and Novartis/ADACAP for Comparison P. Additional trial setup funding was also provided by Janssen Pharmaceutica NV. The MRC CTU receives core funding provided by the UKRI MRC. Please visit our Collaborators and Funders page to find out more about trial funding. 

Interested in joining? A number of hospitals throughout the United Kingdom are due to participate in STAMPEDE2. Please visit our STAMPEDE2 Sites page to find your nearest hospital.