MRC Clinical Trials Unit at UCL
90 High Holborn
2nd Floor
London
WC1V 6LJ
Email: mrcctu.stampede2@ucl.ac.uk
Patients who meet the eligibility criteria in Section 4.4 of the STAMPEDE2 protocol can be considered for the SABR comparison. Recruiting sites will assess metastatic disease burden using CT/MRI scans and baseline Tc-99m bone scan or PET scan to assess number of metastatic bone and non-regional lymph node foci, and presence of visceral metastases. Patients will be classified as either 'SABR-eligible' or 'SABR-ineligible' using the definition in Section 4.5 of the protocol.
Definition of SABR-eligible disease:
Patients will be classified as SABR-eligible if they meet all the following criteria:
Otherwise, patients will be classified as SABR-ineligible.
Inclusion Criteria:
1. Patient still meets all eligibility criteria for registration in Section 4.4 of the STAMPEDE2 protocol.
2. Histological confirmation of prostate adenocarcinoma.
3. Newly diagnosed (de novo) metastatic disease that is considered eligible for SABR according to the definition in Section 4.5 of the STAMPEDE2 Protocol.
4. Patient has started ADT and randomisation is ≤12 weeks since the start of ADT.
5. WHO performance status 0-2 (see Appendix 1 of the STAMPEDE2 protocol).
6. Patient has provided signed informed consent for participation in Comparison S.
Exclusion Criteria:
a) Disease staging and follow-up.
b) Radiotherapy planning procedures.
STAMPEDE2
MRC Clinical Trials Unit at UCL
90 High Holborn
2nd Floor
London
WC1V 6LJ
Email: mrcctu.stampede2@ucl.ac.uk