INSPIRE: INnovative SABR for Prostate Cancer All IREland (NCT07552168) | Clinical Trial Compass
RecruitingPhase 2
INSPIRE: INnovative SABR for Prostate Cancer All IREland
Ireland, United Kingdom136 participantsStarted 2026-04
Plain-language summary
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
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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
✕. 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
✕. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.
✕. 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.
✕. Participation in another concurrent treatment protocol for prostate cancer (not including QoL, survivorship, exercise or registry studies).