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

Study acronym: STAMPEDE2
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Enrollment target: 8000 to 3360v3 Show 8 more changesShow less
    • Primary endpoints: 2 to 1
    • Study sites: 4 to 18
    • Study completion date: Mar 2034 to Mar 2032
    • Interventions: 177Lu-PSMA-617 (Other), Abiraterone Acetate (Drug), Androgen Deprivation Therapy (ADT) (Drug), Androgen Receptor Signalling Inhibitor… to 177Lu-PSMA-617 (Other), Androgen Deprivation Therapy (ADT) (Drug), Androgen Receptor Signalling Inhibitor (ARPI) (Drug), Docetaxel (Drug)…
    • Eligibility criteria shortened, about 829 words
    • Secondary endpoints: 6 to 8
    • Collaborators: 3 to 2
    • Study arms: 6 to 4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Apr 2024 to Jun 11, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06320067
Lead Sponsor University College, London
Collaborators: Cancer Research UK, Novartis
Conditions
(from sponsor)		 Prostate Cancer Metastatic
Enrollment 3,360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov