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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Gert
Attard
g.attard@ucl.ac.uk
Prof
Nicholas
James
nick.james@icr.ac.uk
Dr
Study
Team
mrcctu.stampede2@ucl.ac.uk
Prof
Louise
Brown
l.brown@ucl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Metastatic hormone-sensitive prostate cancer
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.
Background and study aims
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.
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:
2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37507278/ (added 10/02/2026)
You can take part if:
Current inclusion criteria as of 11/08/2025:
General 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.
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 the 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.
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
a. ANC ≥1.5 x 109/L
b. Platelets ≥100 x 109/L
c. Haemoglobin ≥9g/dL, independent of transfusions for at least 28 days
Hepatic function
a. Total bilirubin ≤2 x ULN. For patients with Gilbert’s Syndrome ≤3 x ULN is permitted.
b. AST and/or ALT performed with all results ≤3 × ULN or ≤5 x ULN for patients with liver metastasis
Renal Function
a. EGFR ≥50 mL/min/1.73m2 calculated using the MDRD formula
b. Albumin ≥25g/L
5. Patient has started ADT and randomisation is ≤12 weeks since the start of current ADT.
6. If relapsed disease, prior LHRH agonist/antagonist with or without first generation anti-androgen 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 mont
You may not be able to take part if:
Current exclusion criteria as of 11/08/2025:General 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; non-melanomatous 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.
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.:a. Disease staging and follow-up.b. 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.
Exclusion Criteria For Comparison P Testing 177Lu-PSMA-617:1. Prior treatment with any of the following:a. Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223b. PSMA-targeted radioligand therapy2. 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).
Previous exclusion criteria:General exclusion criteria1. Clinically and pathologically overt small cell carcinoma2. Metastatic brain disease or leptomeningeal disease3. 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; non-melanomatous 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 ARSI or the trial treatments in the comparison for which they are being considered.
Exclusion criteria For comparison S testing SABR1. Prior radical treatment to the prostate (e.g., radical surgery and/or radiotherapy).2. Intracranial metastatic disease3. Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA)4. 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)5. Any condition or co-morbidities in the judgement of the clinician that precludes procedures required to facilitate radiotherapy delivery e.g.5.1. Disease staging and follow-up5.2. Radiotherapy planning procedures6. Any condition or co-morbidities in the judgement of the clinician that precludes 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)7. Active malignancy other than prostate cancer within the last 36 months8. Contraindication to MRI (e.g., pacemakers, except MRI-compatible pacemakers)
Exclusion criteria For comparison P testing 177LU-PSMA-6171. Prior treatment with any of the following:1.1. Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-2231.2. PSMA-targeted radioligand therapy2. Symptomatic cord compression, or clinical/radiological findings indicative of impending cord compression3. Any condition that precludes raised arms position4. 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)
Exclusion criteria For comparison N testing NIRAPARIB-AA+P1. Prior treatment with a poly ADP ribose polymerase (PARP) inhibitor, radiopharmaceutical or any chemotherapy for prostate cancer other than docetaxel outside the STAMPEDE2 trial.2. History of adrenal dysfunction.3. History or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).4. Known allergies, hypersensitivity, or intolerance to the excipients of AA, or Nira-AA DAT (refer to the IBs for Nira-AA DAT and AA).5. Current evidence of any medical condition that would make prednisolone use contraindicated.6. Presence of sustained uncontrolled hypertension. At randomisation, sites will be asked to provide one blood pressure reading (systolic <160 mmHg and diastolic blood pressure reading <100 mmHg) recorded within the 8 weeks prior to randomisation.7. Received an investigational intervention not related to the STAMPEDE2 trial (including investigational vaccines) or used an invasive investigational medical device within 30 days of randomisation.8. >6 months from start of current ADT to randomisation.9. Participants who have had the following ≤28 days prior to randomisation:9.1. A transfusion (platelets or red blood cells);9.2. Hematopoietic growth factors;9.3. Surgery requiring general anaesthetic10. Known active hepatitis B virus (e.g., hepatitis B surface antigen reactive) or active hepatitis C virus (HCV; e.g., HCV ribonucleic acid [RNA] [qualitative] is detected).11. Known HIV infection and any one of the following:11.1. AIDS-defining opportunistic infection within 6 months of randomisation11.2. HAART or ART regimen non-compatible with the drugs of the study due to drug-drug interaction with Niraparib (e.g., Protease inhibitors, cobicistat, efavirenz, nevirapine, etravirine, doravirine and rilpivirine)11.3. CD4 count below 300/mm3 within the 8 weeks prior to randomisation.11.4. Detectable viral load within the 8 weeks prior to randomisation.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Gert
Attard
g.attard@ucl.ac.uk
Prof
Louise
Brown
l.brown@ucl.ac.uk
Prof
Nicholas
James
nick.james@icr.ac.uk
Dr
Study
Team
mrcctu.stampede2@ucl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University College London and funded by Advanced Accelerator Applications, a Novartis company; Cancer Research UK; UK Research and Innovation; Johnson and Johnson (during set-up phase).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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