STAMPEDE2

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  1006437

• Contact name

  Nicholas James

• Contact email

  nick.james@icr.ac.uk

• Sponsor organisation

  University College London

• Research summary

  STAMPEDE2 is a clinical trial comparing three new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial.

  Each comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care.

  Participants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment.

  Comparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR))
  • Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison.

  Comparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617))
  • Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison.

  Comparison N: Arm A(N) versus Arm N (Niraparib-Abiraterone Acetate+Prednisolone (Nira-AA+P))
  • Tests whether giving a new drug (Nira-AA+P) slows the spread of the cancer and improves survival. Only people with certain genetic changes in their tumour sample can take part in Comparison N. 682 people will be in this comparison.

  Participants may be able to take part in more than one comparison.

  All participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  23/LO/0415

• Date of REC Opinion

  19 Sep 2023

• REC opinion

  Further Information Favourable Opinion