INSPIRE: INnovative SABR for Prostate Cancer All IREland
This is a Phase II, single arm, multi-centre, prospective clinical trial evaluating next generation Stereotactic Ablative Radiotherapy (SABR) for low, intermediate, and eligible high-risk prostate cancer. Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies
• 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)