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Contact Information:

Pamela Niem +442076704921
mrcctu.stampede2@ucl.ac.uk


Aaron Horsey +442076704921
mrcctu.stampede2@ucl.ac.uk


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Be Part of Research - Trial Details - A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
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A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Recruiting

Open to: MALE

Age: 18.0 - N/A

London Sutton London London Plymouth Oxford Portsmouth Romford Middlesbrough London Exeter Sutton in Ashfield Cambridge Exeter London Barnsley Harlow Stockton-on-Tees

Medical Conditions

Prostate Cancer Metastatic

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


STAMPEDE2 is a clinical trial comparing two 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.

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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jun 2024 Apr 2031

INTERVENTIONAL

Intervention Type : RADIATION
Intervention Description : SABR is a way of giving focused high-dose radiotherapy. SABR given with a dose fractionation schedule of 27-30Gy in 3-5 fractions over 1-2 weeks to up to 5 metastatic lesions in the bone and/or non-regional (extra-pelvic) lymph nodes.

Intervention Arm Group : Arm S of SABR Comparison;

Intervention Type : OTHER
Intervention Description : 177Lu-PSMA-617 is a nuclear medicine therapy. Patients will receive 177Lu-PSMA-617 to a dose of 7.4GBq. Each cycle will consist of 2 doses, 1 week apart (on day 1 and day 8) and will last 6 weeks. Treatment will be given for up to 3 cycles (6 doses).

Intervention Arm Group : Arm P of 177Lu-PSMA-617 Comparison;

Intervention Type : DRUG
Intervention Description : Long-term, continuous treatment with ADT (bilateral orchidectomy, LHRH agonists or LHRH antagonists) if not previously surgically castrated. The choice of ADT is at the discretion of the investigator. This will be given as standard of care as per local guidelines.

Intervention Arm Group : Arm A of 177Lu-PSMA-617 Comparison;Arm A of SABR Comparison;Arm P of 177Lu-PSMA-617 Comparison;Arm S of SABR Comparison;

Intervention Type : DRUG
Intervention Description : Second generation ARPI (Abiraterone Acetate and Prednisolone, Enzalutamide, Apalutamide or Darolutamide). This will be given as standard of care as per local guidelines.

Abiraterone acetate will be administered as a single 1000mg once daily dose (4 tablets to be taken together once a day) with prednisolone 5mg once daily to prevent secondary mineralocorticoid excess.

Enzalutamide will be administered as a 160mg oral dose (four capsules taken together at the same time every day) with or without food. Enzalutamide is administered daily in 28-day cycles.

Apalutamide will be administered as 240mg oral dose (four tablets taken together at the same time every day) with or without food. Apalutamide is administered daily in 28-day cycles. Patients require thyroid function monitoring.

Darolutamide will be administered as 600mg oral dose (two 300mg tablets taken together) with or without food. Darolutamide is administered twice daily in 28-day cycles.

Intervention Arm Group : Arm A of 177Lu-PSMA-617 Comparison;Arm A of SABR Comparison;Arm P of 177Lu-PSMA-617 Comparison;Arm S of SABR Comparison;

Intervention Type : RADIATION
Intervention Description : Either 36.25Gy given in 5 fractions over 1-2 weeks to prostate or 60Gy in 20 fractions over 4 weeks to prostate (± 44-47Gy in 20 fractions to pelvic lymph nodes ± 51Gy in 20 fractions boost to involved nodes).

Intervention Arm Group : Arm A of 177Lu-PSMA-617 Comparison;Arm A of SABR Comparison;Arm P of 177Lu-PSMA-617 Comparison;Arm S of SABR Comparison;

Intervention Type : DRUG
Intervention Description : Maximum of 6 cycles every 3 weeks may be given at a dose of 75mg/m2 by IV infusion.

Intervention Arm Group : Arm A of 177Lu-PSMA-617 Comparison;Arm A of SABR Comparison;Arm P of 177Lu-PSMA-617 Comparison;Arm S of SABR Comparison;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden Hospital
    London
    SW3 6JJ
  • The Royal Marsden Hospital
    Sutton
    SM2 5PT
  • Royal Free Hospital
    London
  • Barts Health NHS Trust
    London
  • Derriford Hospital
    Plymouth
  • Churchill Hospital
    Oxford
  • Queen Alexandra Hospital
    Portsmouth
  • Barking, Havering and Redbridge University Hospitals Nhs Trust
    Romford
  • The James Cook University Hospital
    Middlesbrough
  • North Middlesex Hospital
    London
  • Royal Devon & Exeter Hospital
    Exeter
  • Kings Mill Hospital
    Sutton in Ashfield
  • Addenbrookes
    Cambridge
  • Royal Devon University Hospital Trust
    Exeter
    EX2 5DW
  • University College London Hospitals NHS Foundation Trust
    London
    NW3 2PG
  • Mount Vernon Hospital
    Barnsley
  • The Princess Alexandra Hospital
    Harlow
  • North Tees Health NHS Trust
    Stockton-on-Tees

Pamela Niem +442076704921
mrcctu.stampede2@ucl.ac.uk


Aaron Horsey +442076704921
mrcctu.stampede2@ucl.ac.uk



The study is sponsored by University College, London and is in collaboration with Cancer Research UK; Novartis.




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Read full details for Trial ID: NCT06320067
Last updated 22 September 2025

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