STAMPEDE2: A randomised controlled platform trial testing treatments in metastatic hormone sensitive prostate cancer
Trial Summary:
Studying Treatments in patients receiving androgen deprivation therapy (ADT) and androgen receptor signalling inhibitors (ARSI) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2)
Comparison S Prostate SABR/CRT QA summary:
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
| QA Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | |
| Outlining Benchmark Case | | 1 case per centre from the PI, to cover prostate and pelvic nodes. Streamlined (per PI) via NIHR prostate trials. | |
| Planning Benchmark Case | | 1 prostate SBRT case and 1 prostate and pelvic nodes CRT case per centre, subject to streamlining. New benchmark only if centre has changed technique/equipment since (please discuss process with RTTQA contact) |
|
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective / Retrospective outlining and planning case reviews per treatment arm to be advised by RTTQA contact |
| Data collection | |||
| Dosimetry | During accrual | | Subject to streamlining via audit from clinical trial QA groups and UK dosimetry audit network groups |
| QA Streamlining | All activities | | PACE-A/B/C, PACE-NODES, PEARLS, PIVOTALboost |
Comparison S Oligomet SABR QA summary:
All QA activity will be streamlined with previous trial QA or SABR QA programmes, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
| QA Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire | | 2024 SABR QA Programme: FQ required |
| Outlining Benchmark Case | | All centres should already have ≥2 clinicians approved through streamlining or cascade training. Benchmark only if centre has <2 clinicians accredited (1 case per anatomical site) | |
| Planning Benchmark Case | | All centres should already be credentialed through streamlining. Benchmark only if centre has changed technique/equipment since (please discuss process with RTTQA contact) | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective contouring: 1st patient per clinician, per anatomical site, subject to streamlining. Prospective planning: 1st patient per anatomical site, subject to streamlining. Retrospective: N/A |
| Data collection | |||
| Dosimetry | Pre-accrual Lung or Spine SABR audits | | Lung audit: bone and node only Spine audit: bone, node and spine Subject to streamlining |
| QA Streamlining | All activities | | CtE, SEP, HALT, TRAP, SARON, STAR-TRAP, ATLANTA, SOPRANO |
RTTQA Contact: rmh-tr.stampede2.rtqa@nhs.net
Overall Co-Chief Investigators: Professor Nick James, Professor Gert Attard
Comparison S Chief Investigators: Professor Nick van As, Dr Hoda Abdel-Aty
Sponsor: MRC University College London mrcctu.stampede2@ucl.ac.uk
Funder: CRUK, Novartis/AAA, Janssen Pharmaceutica NV, UKRI MRC