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INSPIRE: INnovative SABR for Prostate Cancer All IREland

RecruitingPhase 2Ages 18 Years - anyMaleCancer Trials Ireland
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Written informed consent obtained prior to any study-related procedures 2. Males โ‰ฅ 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 โ‰ค 4+3 6. Clinical and/or MRI stage T1c-T3a, N0-X, M0-X 7. PSA โ‰ค 30 ng/ml (within 60 days prior to registration / prior to starting androgen-deprivation therapy (ADT/hormone therapy) \[PSA โ‰ค 15 ng/ml for patients on 5-alpha reductase inhibitors\] 8. Patients belonging to one of the following risk groups: * Low risk - patients meeting all of the following criteria: * Gleason โ‰ค 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 - โ‰ค30 ng/ml (within 60 days prior to registration) Exclusion Criteria: 1. 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 2. Prior pelvic radiotherapy 3. 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. 4. Life expectancy \<5 years. 5. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts 6. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms. 7. 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. 8. Participation in another concurrent treatment protocol for prostate cancer (not including QoL, survivorship, exercise or registry studies).
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What it tests

  • Next generation Stereotactic Ablative Radiotherapy (SABR)
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Where

4 sites
St Luke's Centre for Radiation Oncology at Beaumont Hospital
Dublin, Ireland
Bon Secours - UPMC Hillman
Cork, Ireland
UPMC Hillman Cancer Centre at Whitfield Hospital
Waterford, Ireland
Northern Ireland Cancer Centre (NICC)
Belfast, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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