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Prostate Cancer MetastaticPhase 3STAMPEDE2NCT06320067

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

A Phase 3 study testing Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617 and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer Metastatic, run by University College, London at 18 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617 and Androgen Deprivation Therapy (ADT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,360 participants
Where
18 sitesUnited Kingdom
Study dates
11 Jun 2024to Mar 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patient has relapsed prostate cancer.
  • Prior radical treatment to the prostate (e.g., radical surgery and/or radiotherapy).
  • Intracranial metastatic disease.
  • Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA).
  • 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).
  • Any condition or co-morbidities that, in the judgement of the clinician, preclude procedures required to facilitate radiotherapy delivery e.g.:
Show all 37Show fewer
  • Disease staging and follow-up.
  • Radiotherapy planning procedures.
  • 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).
  • 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:
  • Patient still meets all eligibility criteria for registration.
  • Histological confirmation of prostate adenocarcinoma.
  • Patient meets the definition of SABR ineligible disease.
  • Patients must have adequate organ function as indicated by blood tests within 4 weeks prior to randomisation:
  • Bone marrow function
  • ANC ≥1.5 x 109/L
  • Platelets ≥100 x 109/L
  • Haemoglobin ≥9g/dL, independent of transfusions for at least 28 days Hepatic function
  • <!-- -->
  • Total bilirubin ≤2 x ULN. For patients with Gilbert's Syndrome ≤3 x ULN is permitted.
  • AST and/or ALT performed with all results ≤3 × ULN or ≤5 x ULN for patients with liver metastasis Renal Function
  • <!-- -->
  • EGFR ≥50 mL/min/1.73m2 calculated using the MDRD formula
  • Albumin ≥25g/L
  • Patient has started ADT and randomisation is ≤12 weeks since start of current ADT.
  • 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.
  • WHO performance status 0-2 (see Appendix 1).
  • Patient has provided signed informed consent for participation in Comparison P.
  • Prior treatment with any of the following:
  • Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223
  • PSMA-targeted radioligand therapy
  • Symptomatic cord compression, or clinical/radiological findings indicative of impending cord compression.
  • Any condition that precludes raised arms position.
  • 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.
  • Imaging Sub-study only: Contraindication to MRI (e.g., pacemakers, except MRI compatible pacemakers).

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pamela Niem contact

+442076704921

mrcctu.stampede2@ucl.ac.uk

Aaron Horsey contact

+442076704921

mrcctu.stampede2@ucl.ac.uk

18 sites in 1 country

United Kingdom18 sites, 18 recruiting

  • Mount Vernon Hospital

    Barnsley

    Recruiting

  • Addenbrookes

    Cambridge

    Recruiting

  • Royal Devon University Hospital Trust

    Exeter, EX2 5DW

    Recruiting

  • Royal Devon & Exeter Hospital

    Exeter

    Recruiting

  • The Princess Alexandra Hospital

    Harlow

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW3 2PG

    Recruiting

  • The Royal Marsden Hospital

    London, SW3 6JJ

    Recruiting

  • Barts Health NHS Trust

    London

    Recruiting

  • North Middlesex Hospital

    London

    Recruiting

  • Royal Free Hospital

    London

    Recruiting

  • The James Cook University Hospital

    Middlesbrough

    Recruiting

  • Churchill Hospital

    Oxford

    Recruiting

  • Derriford Hospital

    Plymouth

    Recruiting

  • Queen Alexandra Hospital

    Portsmouth

    Recruiting

  • Barking, Havering and Redbridge University Hospitals NHS Trust

    Romford

    Recruiting

  • North Tees Health NHS Trust

    Stockton-on-Tees

    Recruiting

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

  • Kings Mill Hospital

    Sutton in Ashfield

    Recruiting

Other trials in United Kingdom

About this study

Official title: Studying Treatments in Patients Receiving Androgen Deprivation Therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and Radiation Efficacy: A 2nd Multi-arm Multi-stage Randomised Controlled Trial (STAMPEDE2).

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.

Read more

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.

Being tested
Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617, Androgen Deprivation Therapy (ADT), Androgen Receptor Signalling Inhibitor (ARPI), Radiotherapy to Prostate ± Pelvic Nodes
Keywords
Hormone sensitive metastatic prostate cancer, Stereotactic ablative body radiotherapy (SABR), PSMA-Lutetium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Ablative Body Radiotherapy (SABR)Radiation

    Also called Stereotactic body radiotherapy (SBRT)

    SABR is a way of giving focused high-dose radiotherapy. SABR given with a dose fractionation schedule of 27-30Gy in 3-5 fractions over 1-2 weeks to up to 5 metastatic lesions in the bone and/or non-regional (extra-pelvic) lymph nodes.

  • 177Lu-PSMA-617Other

    Also called Lutetium (177Lu) Vipivotide Tetraxetan, AAA617, Pluvicto

    177Lu-PSMA-617 is a nuclear medicine therapy. Patients will receive 177Lu-PSMA-617 to a dose of 7.4GBq. Each cycle will consist of 2 doses, 1 week apart (on day 1 and day 8) and will last 6 weeks. Treatment will be given for up to 3 cycles (6 doses).

  • Androgen Deprivation Therapy (ADT)Drug

    Long-term, continuous treatment with ADT (bilateral orchidectomy, LHRH agonists or LHRH antagonists) if not previously surgically castrated. The choice of ADT is at the discretion of the investigator. This will be given as standard of care as per local guidelines.

  • Androgen Receptor Signalling Inhibitor (ARPI)Drug

    Second generation ARPI (Abiraterone Acetate and Prednisolone, Enzalutamide, Apalutamide or Darolutamide). This will be given as standard of care as per local guidelines.

    Abiraterone acetate will be administered as a single 1000mg once daily dose (4 tablets to be taken together once a day) with prednisolone 5mg once daily to prevent secondary mineralocorticoid excess.

    Enzalutamide will be administered as a 160mg oral dose (four capsules taken together at the same time every day) with or without food. Enzalutamide is administered daily in 28-day cycles.

    Apalutamide will be administered as 240mg oral dose (four tablets taken together at the same time every day) with or without food. Apalutamide is administered daily in 28-day cycles. Patients require thyroid function monitoring.

    Darolutamide will be administered as 600mg oral dose (two 300mg tablets taken together) with or without food. Darolutamide is administered twice daily in 28-day cycles.

  • Radiotherapy to Prostate ± Pelvic NodesRadiation

    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).

  • DocetaxelDrug

    Maximum of 6 cycles every 3 weeks may be given at a dose of 75mg/m2 by IV infusion.

Study groups in NCT06320067
Study groupRoleWhat they receive
Arm A of SABR ComparisonActive comparatorSoC (ADT + ARPI ± docetaxel + local RT)
Receives: Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Signalling Inhibitor (ARPI); Radiation: Radiotherapy to Prostate ± Pelvic Nodes; Drug: Docetaxel
Arm S of SABR ComparisonExperimentalSoC (ADT + ARPI ± docetaxel + local RT) + SABR
Receives: Radiation: Stereotactic Ablative Body Radiotherapy (SABR); Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Signalling Inhibitor (ARPI); Radiation: Radiotherapy to Prostate ± Pelvic Nodes; Drug: Docetaxel
Arm A of 177Lu-PSMA-617 ComparisonActive comparatorSoC (ADT + ARPI ± docetaxel ± local RT)
Receives: Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Signalling Inhibitor (ARPI); Radiation: Radiotherapy to Prostate ± Pelvic Nodes; Drug: Docetaxel
Arm P of 177Lu-PSMA-617 ComparisonExperimentalSoC (ADT + ARPI ± docetaxel ± local RT) + 177Lu-PSMA-617
Receives: Other: 177Lu-PSMA-617; Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Signalling Inhibitor (ARPI); Radiation: Radiotherapy to Prostate ± Pelvic Nodes; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as time from randomisation to death from any cause.

    The final reporting times of OS for each comparison below will depend on the recruitment rates and the accuracy of assumed median survival times in the sample size calculations.

    Measured: Final analysis for each comparison triggered when adequate number of death events have occurred in control arm of each comparison. Anticipate final reporting for OS in Comparison S: ~84 months (7 years) from FPFV, P: ~64 months (5.3 years) from FPFV.

Secondary outcomes (8)

  1. Failure-Free Survival (FFS)

    Time from randomisation until the first of:

    • Biochemical progression
    • Clinical progression such as symptomatic local progression leading to intervention
    • Radiographic confirmed progression including local progression, pelvic lymph node progression, progression of an existing metastatic site or development of new metastatic site defined as lymph nodes outside the pelvis, bone or organ involvement
    • Symptomatic skeletal-related events secondary to cancer progression
    • Death from any cause

    Measured: Up to 10 years from randomisation. FFS is declared as a secondary outcome and is not part of sample size calculations, nor timelines for the study.

  2. Radiographic Progression-Free-Survival (rPFS)

    Time from randomisation until the first of:

    • Radiographic confirmed progression of an existing metastatic site or development of a new metastatic site defined as lymph nodes outside the pelvis, bone or organ involvement
    • Symptomatic skeletal-related events secondary to cancer progression
    • Death from any cause

    Measured: Up to 10 years from randomisation. rPFS is declared as a secondary outcome and is not part of sample size calculations, nor timelines for the study.

  3. Prostate cancer specific survival (PCSS)

    Time from randomisation to death from prostate cancer.

    Measured: Up to 10 years from randomisation. PCSS is declared as a secondary outcome and is not part of the sample size calculations, nor timelines for the study.

  4. Safety through reporting of SAEs

    Measured: S: until 6 months after randomisation; P: until 6 months after randomisation or 40 days after completion or permanent discontinuation of an IMP 177Lu-PSMA-617 (whichever is furthest); N: until 30 days after permanent discontinuation of an IMP

  5. Toxicity using CTCAE classification and reporting of all Adverse Events that are ≥ grade 3 or grade 1 and 2 leading to a change in trial treatment

    Measured: All safety and toxicity data will be presented by randomised group. The exact nature of this will be pre-specified in the statistical analysis plan that is still in development.

  6. Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development.

    Measured: Randomisation until death or end of trial treatment (up to 10 years from randomisation).

  7. Resource use for cost-effectiveness assessment

    Measured: Randomisation until death or end of trial treatment (up to 10 years from randomisation).

  8. EQ-5D-5L questionnaire for QoL and cost effectiveness assessment

    Measured: From date of randomisation until death or end of trial, whichever came first (up to 10 years from randomisation). The end of the trial will be determined by the timelines described in the primary outcomes section.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start11 Jun 2024
  3. Primary completionApr 2031 (estimated)
  4. Study completionMar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Platform trial testing two research comparisons where patients are randomised either to experimental treatments in Arms S and P or their corresponding SoC control Arms A(S) and A(P).
Masking
None (open label)
Enrolment
3,360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06320067
Sponsor's protocol ID
PR12
Other IDs
1006437
Acronym
STAMPEDE2
Status last verified
Sep 2025
First submitted
10 Jan 2024
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared according to the CTU's controlled access approach based on principles outlined in the trial protocol. Requests for sharing data will need to provide detail on the specific requirements, proposed research, qualifications of researchers and publication plan. All non-identifiable data will be available for sharing if approved following the CTU review process. Access to the digital image repository and the stored pathological tissue from researchers outside of the MRC CTU will be obtained through a formal data sharing application detailing the specific requirements, proposed research, investigator qualifications and publication plan. Applications for access to tissue are required separately from access to the shared clinical data.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617 and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer Metastatic, run by University College, London at 18 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pamela Niem (+442076704921, mrcctu.stampede2@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Final analysis for each comparison triggered when adequate number of death events have occurred in control arm of each comparison. Anticipate final reporting for OS in Comparison S: ~84 months (7 years) from FPFV, P: ~64 months (5.3 years) from FPFV.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06320067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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