Next-generation SABR for prostate cancer across Ireland

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multi-centre Phase II study delivering next-generation prostate SABR that prioritises the dominant intraprostatic lesion (DIL) while sparing the urethra, bladder trigone, rectum, and neurovascular bundles. Planned dosing delivers a DIL boost (40–50 Gy in 5 fractions) with lower-dose coverage to the whole prostate CTV/PTV and constrained urethral doses, and peri-rectal hydrogel spacers are placed before simulation to lower rectal dose. Treatment uses advanced image guidance with fiducials and protocol-defined dosimetric constraints, and selected intermediate/high-risk patients may receive 6–12 months of androgen-deprivation therapy at physician discretion. Patients are followed for clinical outcomes and toxicity to determine whether this approach maintains cancer control with reduced genitourinary, rectal, and sexual side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 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).

Where it's running

• Bon Secours - UPMC Hillman
  Cork, Ireland Recruiting
• UPMC Hillman Cancer Centre at Whitfield Hospital
  Waterford, Ireland Recruiting
• St Luke's Centre for Radiation Oncology at Beaumont Hospital
  Dublin, Leinster, Ireland Not yet recruiting
• Northern Ireland Cancer Centre (NICC)
  Belfast, Ulster, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Cancer Trials Ireland
• Email: info@cancertrials.ie
• Phone: +35316677211

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Relugolix to improve PSMA PET/CT imaging in men with high or very high risk prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.