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Looking for participantsPhase3

A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Sponsor: University College, London

NCT ID: NCT06320067

View on ClinicalTrials.gov ↗

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.

Prostate Cancer Metastatic

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

EGFR

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
Registration Inclusion Criteria: 1. At least 18 years old. 2. Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation. 3. Confirmation of metastatic site(s) on CT/MRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible: * Metastatic disease to the bone (in any distribution). * Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis. * Visceral metastases of any size or distribution. 4. Clinical presentation is: A. de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI) will have been completed ≥2 years prior to any future randomisation into any of the comparisons, and; (3) will have received ≤3 years total of ADT at the point of randomisation into any comparison. Note: the dates will be checked again at randomisation. It is the responsibility of the investigator to account for the time between registration and randomisation into any comparison. 5. Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years. 6. WHO Performance Status 0-2 or, if WHO Performance Status 3, deemed to be due to metastatic burden and expected to improve with ADT. Note: Improvement to WHO status 0-2 will be checked again at randomisation into any subsequent comparison. Note: For WHO performance status definitions see Appendix 1. 7. Willing and able to comply with trial treatments. 8. Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform. Registration Exclusion Criteria: 1. Clinically and pathologically overt small cell carcinoma. 2. Metastatic brain disease or leptomeningeal disease. 3. Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; nonmelanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence). 4. Any other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long-term ADT or the trial treatments in the comparison for which they are being considered. Eligibility Criteria For Comparison S Testing SABR: Patients who meet the general eligibility criteria can be considered for the SABR comparison. Recruiting sites will assess metastatic disease burden using CT/MRI scans and baseline Tc-99m bone scan or PET scan to assess number of metastatic bone and non-regional lymph node foci, and presence of visceral metastases. Patients will be classified as either 'SABR-eligible' or 'SABR-ineligible' using the following definition. Definition of SABR-eligible disease: Patients will be classified as SABR-eligible if they meet all the following criteria: * 1-5 metastatic lesions (including either bone and/or non-regional lymph node sites). * Clinician determination that metastatic lesions are considered suitable for SABR on technical grounds (such as proximity of dose limiting normal tissue or tumour volume). Note: Clinical determination can consider next-generation imaging (e.g., PSMA PET-CT or WBMRI) where available. It is the investigator's responsibility to consider the impact of any findings on the suitability of SABR for the patient. Any next-generation imaging used prior to randomisation should be declared at randomisation so that it can be used as a stratification factor. * Absence of visceral metastases. Otherwise, patients will be classified as SABR-ineligible. In addition to the general registration eligibility criteria, they need to meet all the following criteria for entry into Comparison S: 1. Patient still meets all eligibility criteria for registration in Section 4.4. 2. Histological confirmation of prostate adenocarcinoma. 3. Newly diagnosed (de novo) metastatic disease that is considered eligible for SABR according to the above definition. 4. Patient has started ADT and randomisation is ≤12 weeks since the start of ADT. 5. WHO performance status 0-2 (see Appendix 1). 6. Patient has provided signed informed consent for participation in Comparison S. Exclusion Criteria For Comparison S Testing SABR: 1. Patient has relapsed prostate cancer. 2. Prior radical treatment to the prostate (e.g., radical surgery and/or radiotherapy). 3. Intracranial metastatic disease. 4. Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA). 5. Significant or progressive neurological deficit such that emergency (within 24 hours) surgery or radiation required (e.g., metastatic spinal cord compression, or impingement of the cord or any other clinical scenario whereby urgent radiotherapy to the spine is required). 6. Any condition or co-morbidities that, in the judgement of the clinician, preclude procedures required to facilitate radiotherapy delivery e.g.: 1. Disease staging and follow-up. 2. Radiotherapy planning procedures. 7. Any condition or co-morbidities that, in the judgement of the clinician, preclude the safe delivery of radiotherapy to the prostate (± pelvic lymph nodes) and/or metastases e.g., inflammatory bowel disease, significant systemic connective tissue disorder, radiological evidence of idiopathic pulmonary fibrosis). 8. Active malignancy other than prostate cancer within the last 36 months. Eligibility Criteria For Comparison P Testing 177LU-PSMA-617: In addition to the general eligibility criteria, patients need to meet the following criteria for entry into Comparison P: 1. Patient still meets all eligibility criteria for registration. 2. Histological confirmation of prostate adenocarcinoma. 3. Patient meets the definition of SABR ineligible disease. 4. Patients must have adequate organ function as indicated by blood tests within 4 weeks prior to randomisation: Bone marrow function 1. ANC ≥1.5 x 109/L 2. Platelets ≥100 x 109/L 3. Haemoglobin ≥9g/dL, independent of transfusions for at least 28 days Hepatic function <!-- --> 1. Total bilirubin ≤2 x ULN. For patients with Gilbert's Syndrome ≤3 x ULN is permitted. 2. AST and/or ALT performed with all results ≤3 × ULN or ≤5 x ULN for patients with liver metastasis Renal Function <!-- --> 1. EGFR ≥50 mL/min/1.73m2 calculated using the MDRD formula 2. Albumin ≥25g/L 5. Patient has started ADT and randomisation is ≤12 weeks since start of current ADT. 6. If relapsed disease, prior LHRH agonist/antagonist with or without first generation antiandrogen use in the adjuvant/neo-adjuvant setting, hormone treatment must have been discontinued ≥2 years prior to randomisation AND must not have exceeded a total of \>3 years of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy. 7. WHO performance status 0-2 (see Appendix 1). 8. Patient has provided signed informed consent for participation in Comparison P. Exclusion Criteria For Comparison P Testing 177Lu-PSMA-617: 1. Prior treatment with any of the following: 1. Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 2. PSMA-targeted radioligand therapy 2. Symptomatic cord compression, or clinical/radiological findings indicative of impending cord compression. 3. Any condition that precludes raised arms position. 4. Unmanageable bladder outflow obstruction or urinary incontinence. Note: bladder outflow obstruction or urinary incontinence which is manageable and controlled with best available standard of care (incl. drainage, pads) is permitted. 5. Imaging Sub-study only: Contraindication to MRI (e.g., pacemakers, except MRI compatible pacemakers).

Where Is This Study? (18 UK sites)

Mount Vernon Hospital

Barnsley, United Kingdom

Recruiting

Addenbrookes

Cambridge, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Royal Devon University Hospital Trust

Exeter EX2 5DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Royal Devon & Exeter Hospital

Exeter, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

The Princess Alexandra Hospital

Harlow, United Kingdom

Recruiting
Hospital R&D contact (matched)

Chris Cook

nikki.white6@nhs.net01279 978096

University College London Hospitals NHS Foundation Trust

London NW3 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Barts Health NHS Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

North Middlesex Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Deborah McCartney

deborah.mccartney2@nhs.net+44(0)208 887 2307

Royal Free Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

The James Cook University Hospital

Middlesbrough, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089

Churchill Hospital

Oxford, United Kingdom

Recruiting

Derriford Hospital

Plymouth, United Kingdom

Recruiting

Queen Alexandra Hospital

Portsmouth, United Kingdom

Recruiting
Hospital R&D contact (matched)

Joe Shoebridge

research.office@porthosp.nhs.uk023 9228 6236

Barking, Havering and Redbridge University Hospitals NHS Trust

Romford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Heidi Chandler

bhrut.development.research@nhs.net01708 435000 ex 2923

North Tees Health NHS Trust

Stockton-on-Tees, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090

The Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Kings Mill Hospital

Sutton in Ashfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Steel

sfh-tr.researchandinnovation@nhs.net01623 622515 ext 3990

How to Get in Touch

Pamela Niem

Sponsor contact

CONTACT

+442076704921 mrcctu.stampede2@ucl.ac.uk

Aaron Horsey

Sponsor contact

CONTACT

+442076704921 mrcctu.stampede2@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-09