INSPIRE: INnovative SABR for Prostate Cancer All IREland

Prior treatment

• Prior pelvic radiotherapy
• Any prior active treatment for prostate cancer (with the exception of ADT). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
• Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
• Participation in another concurrent treatment protocol for prostate cancer (not including QoL, survivorship, exercise or registry studies).

Other illness

• Previous malignancy within the last 2 years (except basal cell carcinoma (BCC) or squamous carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
• Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.

Lab values

• Anticoagulation with warfarin/bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician. Note: Anti-platelet agents e.g. aspirin, clopidogrel and DOACs such as apixaban, rivaroxaban are not contraindications to trial entry.

Age

• Life expectancy \<5 years.

• Written informed consent obtained prior to any study-related procedures
• Males ≥ 18 years of age
• ECOG performance status (PS) 0-2
• Biopsy-proven prostate adenocarcinoma without neuro-endocrine differentiation (within 18 months prior to registration, unless on active surveillance and re-biopsy not clinically indicated)
• Gleason score ≤ 4+3
• Clinical and/or MRI stage T1c-T3a, N0-X, M0-X
• PSA ≤ 30 ng/ml (within 60 days prior to registration / prior to starting androgen-deprivation therapy (ADT/hormone therapy) \[PSA ≤ 15 ng/ml for patients on 5-alpha reductase inhibitors\]
• Patients belonging to one of the following risk groups:
  • Low risk - patients meeting all of the following criteria:
  • Gleason ≤ 6
  • Clinical stage T1c-T2a
  • PSA \< 10 ng/ml (within 60 days prior to registration)
  • Intermediate risk - patients meeting any of the following criteria, assuming no high-risk features apply:
  • Gleason 7 (3+4 or 4+3)
  • MRI stage T2b-T2c (N0, M0-X)
  • PSA 10-20 ng/ml (within 60 days prior to registration)
  • High risk - patients with tumours that meet a maximum of one of the following criteria:
  • MRI stage T3a (N0, M0)
  • PSA \>20 - ≤30 ng/ml (within 60 days prior to registration)