At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Stereotactic Ablative Body Radiotherapy (SABR) (radiation), 177Lu-PSMA-617 (other), Androgen Deprivation Therapy (ADT) (drug), Androgen Receptor Signalling Inhibitor (ARPI) (drug)
- How long the study runs
- Study runs about 93 months (dates as stated)
- About the drug or intervention
- Stereotactic Ablative Body Radiotherapy (SABR) — radiation: SABR is a way of giving focused high-dose radiotherapy. · 177Lu-PSMA-617 — other: 177Lu-PSMA-617 is a nuclear medicine therapy. · Androgen Deprivation Therapy (ADT) — drug: Long-term, continuous treatment with ADT (bilateral orchidectomy, LHRH agonists or LHRH antagonists) if not previously surgically castrated. · Androgen Receptor Signalling Inhibitor (ARPI) — drug: Second generation ARPI (Abiraterone Acetate and Prednisolone, Enzalutamide, Apalutamide or Darolutamide). · Radiotherapy to Prostate ± Pelvic Nodes — radiation: 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). · Docetaxel — drug: Maximum of 6 cycles every 3 weeks may be given at a dose of 75mg/m2 by IV infusion.
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial looks at treatments for prostate cancer that has spread to other parts of the body and still responds to hormone therapy. It is a 'platform trial', meaning it tests several treatments at the same time, including targeted high-dose radiotherapy called SABR (stereotactic ablative body radiotherapy) and a radioactive medicine called 177Lu-PSMA-617. The sponsor is University College, London.
Who can take part
- Age 18 or over
- Prostate cancer confirmed by tissue testing, or strong suspicion with plans to confirm it later
- Cancer spread shown on scans (CT or MRI, plus bone scan or PET scan) to the bone, lymph nodes outside the pelvis, or internal organs
- Hormone therapy (ADT - androgen deprivation therapy) started or planned for at least 2 years
- For the SABR group: newly diagnosed disease with 1 to 5 spread sites, no cancer in internal organs, and suitable for radiotherapy on technical grounds
- For the 177Lu-PSMA-617 group: disease not suitable for SABR, healthy enough blood, liver and kidney test results, and within 12 weeks of starting ADT
- Well enough to carry out daily activities (WHO performance status 0-2), or status 3 expected to improve with hormone therapy
- Signed consent to take part
Who may not be able to
- A type of prostate cancer called small cell carcinoma
- Cancer spread to the brain or the lining of the brain
- Another active cancer in the last 36 months (with some exceptions like non-invasive bladder cancer and most skin cancers)
- Any other condition that makes the person unfit for hormone therapy or trial treatments
- For the SABR group: prostate cancer that came back after earlier treatment, or prior surgery or radiotherapy to the prostate, or earlier treatment to a spread site
- For the SABR group: urgent spinal cord pressure problems needing surgery or radiotherapy within 24 hours
- For the SABR group: conditions making radiotherapy unsafe, such as inflammatory bowel disease or lung fibrosis
- For the 177Lu-PSMA-617 group: earlier treatment with radioactive bone-targeting medicines (e.g. radium-223) or PSMA-targeted radioactive therapy
- For the 177Lu-PSMA-617 group: spinal cord compression or signs it may be starting
- For the 177Lu-PSMA-617 group: being unable to raise the arms, or bladder blockage or leaking that cannot be managed
What taking part involves
- • Long-term hormone therapy (ADT) for at least 2 years
- • Depending on the comparison joined: SABR (precise high-dose radiotherapy to spread sites) or 177Lu-PSMA-617 (a radioactive medicine that targets prostate cancer cells)
- • Scans such as CT, MRI, bone scans or PET scans to check the cancer and follow it up
Time commitment: Not stated — ask the trial team (the data does not give visit numbers or total duration beyond at least 2 years of hormone therapy).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 3,360
- Started
- 2024-06-11
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer metastatic
- • Phase3 - 3,360 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer metastatic
- • Male only
Where?
- • Barnsley - Mount Vernon Hospital
- • Cambridge - Addenbrookes
- • Exeter - Royal Devon University Hospital Trust
- • Exeter - Royal Devon & Exeter Hospital
- • +14 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
What the study is looking for
- ✓At least 18 years old.
- ✓Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan...
- ✓Confirmation of that has spread site(s) on CT/MRI and either bone or PET scan. Patients with that has spread disease meeting...
- ✓that has spread disease to the bone (in any distribution).
- ✓Visceral metastases of any size or distribution.
Who cannot take part
- ✗Clinically and pathologically overt small cell carcinoma.
- ✗that has spread brain disease or leptomeningeal disease.
- ✗Eligibility Criteria For Comparison S Testing SABR:
- ✗Definition of SABR-eligible disease:
- ✗Patients will be classified as SABR-eligible if they meet all the following criteria:
See the full criteria
Where Is This Study? (18 UK sites)
Mount Vernon Hospital
Barnsley, United Kingdom
Addenbrookes
Cambridge, United Kingdom
Royal Devon University Hospital Trust
Exeter EX2 5DW, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
The Princess Alexandra Hospital
Harlow, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW3 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Royal Marsden Hospital
London SW3 6JJ, United Kingdom
Barts Health NHS Trust
London, United Kingdom
North Middlesex Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
The James Cook University Hospital
Middlesbrough, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom
North Tees Health NHS Trust
Stockton-on-Tees, United Kingdom
Research and Development
nth-tr.ntandh.researchdevelopment@nhs.net01642 624090The Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
Kings Mill Hospital
Sutton in Ashfield, United Kingdom
How to Get in Touch
Pamela Niem
Sponsor contactCONTACT
Aaron Horsey
Sponsor contactCONTACT
