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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,360
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-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).
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.
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.
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).
Maximum of 6 cycles every 3 weeks may be given at a dose of 75mg/m2 by IV infusion.
Mount Vernon Hospital
Barnsley, United Kingdom
RECRUITINGAddenbrookes
Cambridge, United Kingdom
RECRUITINGRoyal Devon University Hospital Trust
Exeter, United Kingdom
RECRUITINGRoyal Devon & Exeter Hospital
Exeter, United Kingdom
RECRUITINGThe Princess Alexandra Hospital
Harlow, United Kingdom
RECRUITINGUniversity College London Hospitals NHS Foundation Trust
London, United Kingdom
RECRUITINGThe Royal Marsden Hospital
London, United Kingdom
RECRUITINGBarts Health NHS Trust
London, United Kingdom
RECRUITINGNorth Middlesex Hospital
London, United Kingdom
RECRUITINGRoyal Free Hospital
London, United Kingdom
RECRUITING...and 8 more locations
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.
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.
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
Time frame: 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.
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
Time frame: 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.
Prostate cancer specific survival (PCSS)
Time from randomisation to death from prostate cancer.
Time frame: 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.
Safety through reporting of SAEs
Time frame: 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
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
Time frame: 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.
Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development.
Time frame: Randomisation until death or end of trial treatment (up to 10 years from randomisation).
Resource use for cost-effectiveness assessment
Time frame: Randomisation until death or end of trial treatment (up to 10 years from randomisation).
EQ-5D-5L questionnaire for QoL and cost effectiveness assessment
Time frame: 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.
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