- INSPIRE: INnovative SABR for Prostate Cancer All IREland — Recruiting • Phase II • Oncology • NCT07552168.
- Sponsor: Cancer Trials Ireland.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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
- : 1. Written informed consent obtained prior to any study-related procedures 2. Males ≥ 18 years of age 3. ECOG performance status (PS) 0-2 4. Biopsy-proven prostate adenocarcinoma without neuro-endocrine differentiation (within 18 months prior to registration, unless on active surveillance and re-biopsy not clinically indicated) 5. Gleason score ≤ 4+3 6. Clinical and/or MRI stage T1c-T3a, N0-X, M0-X 7. 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] 8. 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.