INSPIRE: INnovative SABR for Prostate Cancer All IREland

NCT07552168 | Recruiting Phase 2

• 1 other identifier: 24-72
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Prostate Adenocarcinoma

Keywords

SABR; Prostate cancer; Prostate adenocarcinoma; Low-risk prostate cancer; Intermediate-risk prostate cancer; High-risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Late GU toxicity

  Rate of ≥ Grade 2 version 5 (v5) NCI CTCAE late GU toxicity in next-generation prostate SABR at 2 years.

  2 years after last fraction

Secondary Outcomes (11)

• Acute GU Toxicity

  ≤12 weeks after last fraction

• Acute GI Toxicity

  ≤12 weeks after last fraction

• Late GU toxicity at 5 years

  5 years after last fraction

• Late GI toxicity at 5 years

  5 years after last fraction

• Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via Expanded Prostate Cancer Index Composite Short Form (EPIC-26).

  4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment

Other Outcomes (1)

• Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via Penile Shortening and well being questionnaire (PSW E9).

  Baseline, 6 months and 2 years post treatment.

Study Arms (1)

Next generation Stereotactic Ablative Radiotherapy (SABR)

EXPERIMENTAL

Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies: urethral/trigone sparing, rectal hydrogel spacer, and neurovascular bundle preservation.

Radiation: Next generation Stereotactic Ablative Radiotherapy (SABR)

Interventions

Next generation Stereotactic Ablative Radiotherapy (SABR) RADIATION

Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs).

Next generation Stereotactic Ablative Radiotherapy (SABR)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Life expectancy \<5 years.
• 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).

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (3)

St Luke's Centre for Radiation Oncology at Beaumont Hospital

Dublin, Leinster, D09 FT51, Ireland

NOT YET RECRUITING

Bon Secours - UPMC Hillman

Cork, T12 DV56, Ireland

RECRUITING

Northern Ireland Cancer Centre (NICC)

Belfast, Ulster, BT9 7AB, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Cancer Trials Ireland

CONTACT

+35316677211; info@cancertrials.ie

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): November 1, 2034
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

GB (1); IE (2)