Actively Recruiting
A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
Led by University College, London · Updated on 2025-09-26
3360
Participants Needed
18
Research Sites
402 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
C
Cancer Research UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Histological confirmation or strong clinical suspicion of prostate adenocarcinoma
- Confirmation of metastatic sites on CT/MRI and bone or PET scan
- Metastases to bone, non-regional lymph nodes (with at least one node ≥1.5cm outside pelvis if only lymph nodes), or visceral sites
- Clinical presentation either de novo or relapsed with continuing hormone sensitivity
- Long-term androgen deprivation therapy started or planned for minimum 2 years
- WHO performance status 0-2 or 3 if due to metastatic burden and expected to improve with therapy
- Willing and able to comply with trial treatments
- Signed informed consent for trial registration
You will not qualify if you...
- Clinically and pathologically overt small cell carcinoma
- Metastatic brain or leptomeningeal disease
- Active malignancies other than prostate cancer in last 36 months (except certain low-risk cancers)
- Medical conditions making participant unfit for long-term androgen deprivation therapy or trial treatments
- For Comparison S: relapsed prostate cancer, prior radical prostate treatment, intracranial metastases, prior treatment to metastatic sites, urgent neurological conditions needing immediate treatment, conditions preventing radiotherapy delivery
- For Comparison P: prior specific radiotherapy or PSMA-targeted therapy, symptomatic or impending spinal cord compression, conditions preventing certain positioning or bladder control, MRI contraindications for imaging sub-study
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Mount Vernon Hospital
Barnsley, United Kingdom
Actively Recruiting
2
Addenbrookes
Cambridge, United Kingdom
Actively Recruiting
3
Royal Devon University Hospital Trust
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
4
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Actively Recruiting
5
The Princess Alexandra Hospital
Harlow, United Kingdom
Actively Recruiting
6
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW3 2PG
Actively Recruiting
7
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
8
Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
9
North Middlesex Hospital
London, United Kingdom
Actively Recruiting
10
Royal Free Hospital
London, United Kingdom
Actively Recruiting
11
The James Cook University Hospital
Middlesbrough, United Kingdom
Actively Recruiting
12
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
13
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
14
Queen Alexandra Hospital
Portsmouth, United Kingdom
Actively Recruiting
15
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom
Actively Recruiting
16
North Tees Health NHS Trust
Stockton-on-Tees, United Kingdom
Actively Recruiting
17
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
18
Kings Mill Hospital
Sutton in Ashfield, United Kingdom
Actively Recruiting
Research Team
P
Pamela Niem
CONTACT
A
Aaron Horsey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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