Actively Recruiting
Studying Treatments in Patients Receiving Androgen Deprivation Therapy for Metastatic Prostate Cancer: Evaluation of Drug and Radiation Efficacy in a Multi-arm Randomised Controlled Trial (STAMPEDE2)
Led by University College, London · Updated on 2025-09-26
3360
Participants Needed
18
Research Sites
47 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
Researchers are evaluating two new treatments compared to the best standard care for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This phase 3 trial includes multiple hospitals across the UK and is led by University College London. The study aims to see if adding targeted radiotherapy or a radioactive drug can slow cancer spread and improve survival. Participants are assigned by computer to one of several groups. One group receives standard care, which includes androgen deprivation therapy (ADT) plus other hormone therapies, possible chemotherapy with docetaxel, and local radiotherapy. Another group receives standard care plus targeted high-dose radiotherapy (SABR) to metastatic sites. A third group receives standard care plus a radioactive therapy called 177Lu-PSMA-617, given in cycles with two doses per cycle. Treatments continue unless side effects are severe or participants choose to stop. During the study, participants will have scans and tests to monitor their cancer and side effects. Doctors will check safety and treatment adherence over time. Researchers will measure overall survival, failure-free survival, progression-free survival, prostate cancer-specific survival, and quality of life up to 10 years from randomization. Safety will be closely monitored, and participants’ health will be followed during and after treatment.
CONDITIONS
Brief 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
- Confirmed metastatic sites on CT/MRI and bone or PET scans including bone, non-regional lymph nodes, or visceral metastases
- Newly diagnosed or relapsed hormone-sensitive metastatic prostate cancer with completed hormone treatments at least 2 years prior and total ADT duration up to 3 years
- Started or intend to start long-term ADT for minimum of 2 years
- WHO Performance Status 0-2, or 3 if due to metastatic burden expected to improve with ADT
- Willing and able to comply with trial treatments
- Signed informed consent for trial registration
You will not qualify if you...
- Small cell carcinoma of prostate
- Brain or leptomeningeal metastatic disease
- Active other malignancies progressing or treated in last 36 months except certain low-risk cancers
- Any medical condition making participant unfit or unsuitable for long-term ADT or trial treatments
- For SABR comparison: relapsed cancer, prior radical prostate treatment, intracranial metastases, prior treatment to metastatic site, urgent neurological conditions requiring immediate therapy, conditions preventing radiotherapy delivery or planning, inflammatory bowel disease, connective tissue disorders, or certain lung diseases
- For 177Lu-PSMA-617 comparison: prior radionuclide therapies like Strontium-89 or Radium-223, symptomatic or impending cord compression, inability to raise arms, unmanageable urinary problems, MRI contraindications for imaging sub-study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive standard of care treatment which includes long-term androgen deprivation therapy (ADT) and second generation androgen receptor signalling inhibitors (ARPI). Some may also receive docetaxel chemotherapy and/or local radiotherapy to the prostate and pelvic nodes. Certain participants will receive additional treatments depending on their assigned group: stereotactic ablative body radiotherapy (SABR) to metastatic lesions or 177Lu-PSMA-617 nuclear medicine therapy in cycles.
Multiple visits according to treatment schedules, including up to 6 cycles of docetaxel every 3 weeks, SABR delivered over 1-2 weeks, and 177Lu-PSMA-617 cycles lasting 6 weeks each
Duration - Up to 10 years from randomisation
Participants continue to be monitored for safety, treatment effects, and survival outcomes after treatment ends.
Periodic visits for assessments and questionnaires over follow-up period
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
A
Aaron Horsey
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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