protocolSection identificationModule nctId: NCT06320067, orgStudyIdInfo id: PR12, secondaryIdInfos id: 1006437, type: OTHER, domain: IRAS, briefTitle: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer, acronym: STAMPEDE2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2031-04, completionDateStruct date: 2034-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: Cancer Research UK, collaborators name: Novartis, collaborators name: Janssen Pharmaceutica NV, descriptionModule briefSummary: 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.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.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 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., conditionsModule conditions: Prostate Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Platform trial testing three research comparisons where patients are randomised either to experimental treatments in Arms S, P and N or their corresponding SoC control Arms A and A(N)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Ablative Body Radiotherapy (SABR), interventions name: 177Lu-PSMA-617, interventions name: Niraparib and Abiraterone Acetate Dual Action Tablet DAT, interventions name: Abiraterone Acetate, interventions name: Apalutamide, interventions name: Androgen Deprivation Therapy (ADT), interventions name: Androgen Receptor Signalling Inhibitor (ARSI), interventions name: Local Radiotherapy, interventions name: Prednisolone, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Radiographic Progression-Free-Survival (rPFS), primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Failure-Free Survival (FFS), secondaryOutcomes measure: Prostate cancer specific survival (PCSS), secondaryOutcomes measure: Safety through reporting of SAEs, secondaryOutcomes measure: 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, secondaryOutcomes measure: Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development., secondaryOutcomes measure: EQ-5D-5L questionnaire for QoL and cost effectiveness assessment, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False