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Contact Information:

Prof Louise Brown
None available
l.brown@ucl.ac.uk


Dr Study Team
None available
mrcctu.stampede2@ucl.ac.uk


Prof Nicholas James
+44 (0)20 7153 5131
nick.james@icr.ac.uk


Prof Gert Attard
None provided
g.attard@ucl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Testing the addition of new treatments to standard treatment in prostate cancer that has spread to other areas of the body
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Testing the addition of new treatments to standard treatment in prostate cancer that has spread to other areas of the body

Recruiting

Open to: Male

Age: Mixed

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Medical Conditions

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 three 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:

11 Jun 2024 31 Mar 2030

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 the 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 cancer and improves survival. 1756 people will be in this comparison.

Comparison N: Arm A(N) versus Arm N (Niraparib-Abiraterone Acetate+Prednisolone (Nira-AA+P))
• Tests whether giving a new drug (Nira-AA+P) slows the spread of the cancer and improves survival. Only people with certain genetic changes in their tumour sample can take part in the Comparison N. 682 people will be in this comparison.

Participants may be able to take part in more than one 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.


Adult men aged over 18 years old with prostate cancer

You can take part if:



You may not be able to take part if:


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.

All participants will have been diagnosed with metastatic prostate cancer that requires treatment as part of SoC. The risks and burdens of taking part in STAMPEDE2 over and above their standard care are listed below. Sites will be trained in discussing all these issues with patients as part of the consent procedure for each comparison:
1. As for many clinical trials, participation can lead to an increased risk of toxicities with research treatments. For cancer trials, there are also toxicities associated with the cancer itself as well as the standard of care therapies. The Patient Information Sheet (PIS) documents the likelihood of toxicities associated with the new research therapies so that patients can decide if they wish to take part. Any emerging symptoms or toxicities for a participant will be managed by the site regardless of whether they are caused by the cancer, the standard therapies or research therapies.
2. Some patients will require more frequent visits to the hospital and this is explained in the PIS. For the majority of the time, patient follow-up visits for the trial will coincide with routine follow-up appointments that occur as a result of the patient receiving their SoC treatments. For comparison N, there will be more frequent CT scans up to the point of cancer progression. These will be every 4 months rather than waiting for clinical signs or symptoms to occur which would prompt imaging as part of standard care.
3. A small number of additional fitness tests may be required to check eligibility but the majority of the tests will be done as part of routine care for their cancer. For the translational research blood samples, a small amount of additional blood will be taken whilst the patient is having blood collected for their routine care, thus no need for further venepuncture procedures. They are free to opt out of providing this additional blood but can still take part in the main trial.
4. For patients undergoing biomarker testing, there may be a need for genetic counselling if genetic mutations of known clinical consequence are identified and there may also be consequences for family members of the participant. However, the participant has the option to not receive information on these mutations and this is explained in the PIS and consent form.
5. Due to increased risks of developing myelosuppression and other cumulative toxicities from docetaxel, 177Lu-PSMA-617 and niraparib. Participants randomised to Arm N and P will not be offered docetaxel as part of their SOC. This is estimated to be a small number of participants ( <5%) but it is appreciated that some participants may be concerned about not receiving this treatment. In these cases sites will explain the reasons for the decision and that docetaxel is a treatment of unknown benefit in combination with ARSI in men with high-burden metastatic prostate cancer.
6. Only patients who have not started ARSI will be considered for comparison N and subject to no plan to start ARSI prior to receipt of their tissue biomarker result (up to 2 months). This schedule for starting ARSI is in keeping with SOC for most patients.
7. For patients undergoing 177Lu-PSMA-617 treatment, there will be some restrictions on their lifestyle after each dose is administered. These are outlined in the patient discharge letter which is also uploaded in this submission and will be given to patients after each dose and when they are being consented to participation in Comparison P.
8. For the first 40 and up to the first 100 men who take part in Comparison P, they must agree to take part in the run-in phase. This will require additional safety assessments and imaging requirements over standard care including, blood tests, whole-body MRI, PSMA PET/CT and dosimetry tests. These are important for the investigators to confirm that PSMA-Lu treatment is safe and acceptable in patients with hormone-sensitive disease and that toxicities are not substantially elevated over the SoC arm. The findings from this run-in phase will inform the main phase of the trial but we anticipate that additional testing will not be required and only a pre-treatment PSMA-PET/CT scan will be required in those randomised to the 177Lu-PSMA-617 arm.
9. It is important that the trial participant is aware of the potential risks for any foetus should his partner become pregnant by him whilst he is receiving treatment. Pregnancy in this setting is extremely rare as the ADT hormonal control will make this very unlikely. However, full details have been provided in the PIS and protocol and should any partner become pregnant during the course of the trial we will be required to follow the mother and baby through to full term to record any complications.

Prof Gert Attard
None provided
g.attard@ucl.ac.uk


Prof Nicholas James
+44 (0)20 7153 5131
nick.james@icr.ac.uk


Dr Study Team
None available
mrcctu.stampede2@ucl.ac.uk


Prof Louise Brown
None available
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.


The study is sponsored by University College London and funded by Advanced Accelerator Applications, a Novartis company; Janssen Pharmaceuticals; Cancer Research UK; UK Research and Innovation.




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Read full details for Trial ID: ISRCTN66357938

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Last updated 14 March 2025

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