STAR-TRAP: Phase II clinical trial of using stereotactic body radiotherapy (SBRT) on first line androgen receptor targeted therapy for metastatic prostate cancer
Trial Summary:
The STAR-TRAP trial is a Phase II multicentre randomised controlled study investigating whether stereotactic body radiotherapy (SBRT) improves outcomes when added to first-line androgen receptor pathway inhibitors for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Sponsored by the Institute of Cancer Research (ICR) and funded by Prostate Cancer UK, the trial includes two cohorts: the induced oligometastatic (iOM) group, consisting of patients whose poly-metastatic disease has been downstaged by systemic therapy, and the oligoprogressive (OP) group, comprising patients with limited disease progression on first-line therapy. The study evaluates whether consolidative SBRT alongside standard systemic treatment can enhance failure-free survival in the iOM cohort and delay treatment discontinuation in the OP cohort, while also assessing effects on overall survival, radiological progression-free survival, time to second progression, symptomatic skeletal events, and patient-reported outcomes. Imaging sub-studies using PSMA PET-CT and WBMRI aim to identify patients most likely to benefit. Patients will receive either systemic therapy alone or with SBRT to metastatic sites, following strict quality assurance protocols. Follow-up aligns with standard care to monitor treatment response, disease progression, and adverse effects. This trial could refine metastatic prostate cancer treatment, potentially establishing SBRT as a standard adjunct to systemic therapy.
Prostate SABR 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 by all trial centres | |
| Planning Benchmark Case | | 1 prostate SBRT case, 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 | | The outlining and planning for at least the first cohort of patients recruited by each trial centre will be subject to review |
| Data collection | | ||
| Dosimetry Audit | | Subject to streamlining via audit from clinical trial QA groups and UK dosimetry audit network groups | |
| QA Streamlining | | PACE-A/B/C, PACE-NODES, PEARLS, PIVOTALboost |
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: At least the 1st Patient for each metastatic site |
| Data collection | | ||
| Dosimetry Audit | | ||
| QA Streamlining | | CtE, SEP, HALT, TRAP, SARON, STAR-TRAP, ATLANTA, SOPRANO |
RTTQA Contact: enh-tr.star-trapqa@nhs.net
Chief Investigator: Dr Julia Murray
Sponsor: Institute of Cancer Research (startrap-icrctsu@icr.ac.uk)
Funder: Prostate Cancer UK
CTU Contact: ICR Clinical Trials and Statistics Unit (ICR-CTSU) (startrap-icrctsu@icr.ac.uk)