Prostate AdenocarcinomaPhase 2NCT07552168
INSPIRE: INnovative SABR for Prostate Cancer All IREland
A Phase 2 study testing Next generation Stereotactic Ablative Radiotherapy (SABR) in people with Prostate Adenocarcinoma, run by Cancer Trials Ireland at 4 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Next generation Stereotactic Ablative Radiotherapy (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Apr 2026to Nov 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
- 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)
Who cannot join
- 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).
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Ireland3 sites, 3 recruiting
- Recruiting
Bon Secours - UPMC Hillman
Cork, T12 DV56
Bon Secours - UPMC Hillman, +353214861100
Paul Kelly, Dr
- Not yet recruiting
St Luke's Centre for Radiation Oncology at Beaumont Hospital
Dublin, Leinster, D09 FT51
SLRON at Beaumont Hospital, +35317045500
Brian O'Neill, Professor
- Recruiting
UPMC Hillman Cancer Centre at Whitfield Hospital
Waterford
Whitfield Hospital - UPMC Hillman, + 353 51 337 400
Ciara Lyons, Dr
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Northern Ireland Cancer Centre (NICC)
Belfast, Ulster, BT9 7AB
NICTN at Belfast Trust, +442896152652
Suneil Jain, Professor
About this study
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
Read the detailed description
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: urethral/trigone sparing, rectal hydrogel spacer, and neurovascular bundle preservation [as per Desai POTEN-C trial, Desai et al., 2025].
Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs). Planned doses are: DIL 40-50 Gy in 5 fractions delivered on alternate days, prostate CTV 35 Gy, PTV 33.25 Gy, and urethral PRV 32.5 Gy. Eligible high-risk and some intermediate-risk patients may receive 6-12 months of androgen deprivation therapy (ADT)/hormonal therapy at the physician's discretion, provided they have not received >14 weeks prior to registration.
Radiotherapy planning will include advanced image-guided verification with fiducial markers, pre-treatment dosimetry to minimise dose to OARs, and adherence to protocol-defined constraints for urethra, rectum, and neurovascular bundles. Peri-rectal spacers will be inserted 7-10 days prior to CT-simulation to reduce rectal dose. Dose prioritisation allows full coverage of the DIL while sparing urethra, bladder trigone, and neurovascular bundles to minimise genitourinary, rectal, and sexual toxicity.
Follow-up assessments will include clinical evaluation, toxicity reporting using v5 NCI CTCAE, and patient-reported outcome measures (PRO/QoL) at 2-, 4-, 8-, and 12-weeks post-treatment, 6 and 9 months, and annually up to 5 years. Data on biochemical/clinical failure, progression-free survival, and initiation or re-initiation of ADT will also be collected.
A total of 136 patients will be enrolled to achieve 122 evaluable participants, allowing detection of a statistically significant reduction in Grade ≥2 late genitourinary toxicity compared to historical SABR controls.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Next generation Stereotactic Ablative Radiotherapy (SABR)
- Keywords
- SABR, Prostate cancer, Prostate adenocarcinoma, Low-risk prostate cancer, Intermediate-risk prostate cancer, High-risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation Stereotactic Ablative Radiotherapy (SABR)Radiation
Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Next generation Stereotactic Ablative Radiotherapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late GU toxicity
Rate of ≥ Grade 2 version 5 (v5) NCI CTCAE late GU toxicity in next-generation prostate SABR at 2 years.
Measured: 2 years after last fraction
Secondary outcomes (11)
Acute GU Toxicity
Acute Grade ≥ 2 GU toxicity ≤12 weeks, using v5 NCI CTCAE
Measured: ≤12 weeks after last fraction
Acute GI Toxicity
Acute Grade ≥ 2 GI toxicity ≤12 weeks, using v5 NCI CTCAE
Measured: ≤12 weeks after last fraction
Late GU toxicity at 5 years
Late Grade ≥ 2 GU toxicity at 5 years, using v5 NCI CTCAE
Measured: 5 years after last fraction
Late GI toxicity at 5 years
Late Grade ≥ 2 GI toxicity at 5 years, using v5 NCI CTCAE
Measured: 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).
EPIC-26 will be reported at 4 weeks, 12 weeks, 6, 9, and 12 months following treatment and yearly thereafter (until year 5). Response options for each EPIC item form a Likert scale, and multi- scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.
Measured: 4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment
Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via International Index of Erectile Function (IIEF-5).
IIEF-5 will be reported at 12 weeks, 6 and 12 months following treatment and yearly thereafter (until year 5). IIEF-5 is reported on a scale of 5 to 25 with higher scores representing better function.
Measured: 12 weeks, 6 and 12 months, 24 months, 36 months, 48 months, 60 months after treatment
Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via International Prostate Symptom Score (IPSS).
IPSS will be reported at 4 weeks, 12 weeks, 6, 9, and 12 months following treatment and yearly thereafter (until year 5). The total symptom score of IPSS ranges from 0 to 35 where 0 indicates no symptoms and 35 indicates the patient is severely symptomatic.
Measured: 4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment
Freedom from biochemical or clinical failure.
Freedom from biochemical (Phoenix definition) or clinical (commencement or re-commencement of androgen deprivation therapy >12 weeks after completing the neoadjuvant/adjuvant course of ADT, local recurrence, nodal recurrence and distant metastases) failure.
Measured: The primary timepoint of interest is 5 years from registration.
Disease specific survival and overall survival
Disease specific survival and overall survival
Measured: 5 years from registration.
Progression-free survival (PFS)
Progression-free survival (PFS) - radiographic, clinical or biochemical evidence of local or distant failure.
Measured: 5 years from registration
To assess commencement or re-commencement of androgen deprivation therapy (ADT)
Eligible high-risk patients and some intermediate risk patients may be planned to receive (or may have already commenced) 6-12 months ADT/hormonal therapy at physician's discretion.
Measured: Up to five years post last fraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start23 Apr 2026
- Primary completionSep 2030 (estimated)
- Study completionNov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552168
- Sponsor's protocol ID
- CTRIAL-IE 24-72
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRE: INnovative SABR for Prostate Cancer All IREland
- ClinicalTrials.gov ID
- NCT07552168
- Acronym / sponsor ID
- CTRIAL-IE 24-72
- Conditions
- Prostate Adenocarcinoma
- Keywords
- SABR, Prostate cancer, Prostate adenocarcinoma, Low-risk prostate cancer, Intermediate-risk prostate cancer, High-risk prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Nov 2034 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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: urethral/trigone sparing, rectal hydrogel spacer, and neurovascular bundle preservation [as per Desai POTEN-C trial, Desai et al., 2025].
Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs). Planned doses are: DIL 40-50 Gy in 5 fractions delivered on alternate days, prostate CTV 35 Gy, PTV 33.25 Gy, and urethral PRV 32.5 Gy. Eligible high-risk and some intermediate-risk patients may receive 6-12 months of androgen deprivation therapy (ADT)/hormonal therapy at the physician's discretion, provided they have not received >14 weeks prior to registration.
Radiotherapy planning will include advanced image-guided verification with fiducial markers, pre-treatment dosimetry to minimise dose to OARs, and adherence to protocol-defined constraints for urethra, rectum, and neurovascular bundles. Peri-rectal spacers will be inserted 7-10 days prior to CT-simulation to reduce rectal dose. Dose prioritisation allows full coverage of the DIL while sparing urethra, bladder trigone, and neurovascular bundles to minimise genitourinary, rectal, and sexual toxicity.
Follow-up assessments will include clinical evaluation, toxicity reporting using v5 NCI CTCAE, and patient-reported outcome measures (PRO/QoL) at 2-, 4-, 8-, and 12-weeks post-treatment, 6 and 9 months, and annually up to 5 years. Data on biochemical/clinical failure, progression-free survival, and initiation or re-initiation of ADT will also be collected.
A total of 136 patients will be enrolled to achieve 122 evaluable participants, allowing detection of a statistically significant reduction in Grade ≥2 late genitourinary toxicity compared to historical SABR controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Next generation Stereotactic Ablative Radiotherapy (SABR) | Experimental | Radiation: Next generation Stereotactic Ablative Radiotherapy (SABR)Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies: urethral/trigone sparing, rectal hydrogel spacer, and neurovascular bundle preservation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next generation Stereotactic Ablative Radiotherapy (SABR)Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs). | Radiation | Next generation Stereotactic Ablative Radiotherapy (SABR) |
Primary outcome
Late GU toxicity
Time frame: 2 years after last fraction
Rate of ≥ Grade 2 version 5 (v5) NCI CTCAE late GU toxicity in next-generation prostate SABR at 2 years.
11 secondary outcomes
Acute GU Toxicity
Time frame: ≤12 weeks after last fraction
Acute GI Toxicity
Time frame: ≤12 weeks after last fraction
Late GU toxicity at 5 years
Time frame: 5 years after last fraction
Late GI toxicity at 5 years
Time frame: 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).
Time frame: 4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment
Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via International Index of Erectile Function (IIEF-5).
Time frame: 12 weeks, 6 and 12 months, 24 months, 36 months, 48 months, 60 months after treatment
Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via International Prostate Symptom Score (IPSS).
Time frame: 4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment
Freedom from biochemical or clinical failure.
Time frame: The primary timepoint of interest is 5 years from registration.
Disease specific survival and overall survival
Time frame: 5 years from registration.
Progression-free survival (PFS)
Time frame: 5 years from registration
To assess commencement or re-commencement of androgen deprivation therapy (ADT)
Time frame: Up to five years post last fraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Next generation Stereotactic Ablative Radiotherapy (SABR) in people with Prostate Adenocarcinoma, run by Cancer Trials Ireland at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Trials Ireland (+35316677211, info@cancertrials.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late GU toxicity (time frame: 2 years after last fraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.