Eligibility Criteria for Comparison S

 

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:

  • 1-5 metastatic lesions (including either bone and/or non-regional lymph node sites).
  • Clinician determination that metastatic lesions are considered suitable for SABR on technical grounds (such as proximity of dose limiting normal tissue or tumour volume). Note: Clinical determination can consider next-generation imaging (e.g., PSMA PET-CT or WBMRI) where available. It is the investigator's responsibility to consider the impact of any findings on the suitability of SABR for the patient. Any next-generation imaging used prior to randomisation should be declared at randomisation so that it can be used as a stratification factor.
  • Absence of visceral metastases.

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:

  1. Patient has relapsed prostate cancer.

 

  1. Prior radical treatment to the prostate (e.g., radical surgery and/or radiotherapy).

 

  1. Intracranial metastatic disease.

 

  1. Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA).

 

  1. Significant or progressive neurological deficit such that emergency (within 24 hours) surgery or radiation required (e.g., metastatic spinal cord compression, or impingement of the cord or any other clinical scenario whereby urgent radiotherapy to the spine is required).

 

  1. Any condition or co-morbidities in the judgement of the clinician that precludes procedures required to facilitate radiotherapy delivery e.g: 

    a) Disease staging and follow-up.

    b) Radiotherapy planning procedures.

 

  1. Any condition or co-morbidities that, in the judgement of the clinician, preclude the safe delivery of radiotherapy to the prostate (+/- pelvic lymph nodes) and/or metastases e.g., inflammatory bowel disease, significant systemic connective tissue disorder, radiological evidence of idiopathic pulmonary fibrosis).

 

  1. Active malignancy other than prostate cancer within the last 36 months.