At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Next generation Stereotactic Ablative Radiotherapy (SABR) (radiation)
- How long the study runs
- Study runs about 103 months (dates as stated)
- About the drug or intervention
- Next generation Stereotactic Ablative Radiotherapy (SABR) — radiation: Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs).
- Patient visit burden
- Not specified by the sponsor
In plain English
INSPIRE is a clinical trial run by Cancer Trials Ireland for men with prostate adenocarcinoma (a common type of prostate cancer) across Ireland. It looks at an innovative type of SABR (stereotactic ablative body radiotherapy), which is highly precise radiotherapy delivered in fewer, stronger doses. The trial accepts men whose cancer has not spread beyond a certain stage.
Who can take part
- Men aged 18 or over who give written informed consent
- Reasonably active and able to look after themselves (performance status 0-2)
- Prostate cancer confirmed by biopsy within the last 18 months (unless on active surveillance and a repeat biopsy is not needed)
- Gleason score of 4+3 or lower (a measure of how aggressive the cancer cells look)
- Cancer at an early stage that has not spread to lymph nodes or other parts of the body (stage T1c-T3a)
- PSA (prostate-specific antigen, a blood marker) of 30 ng/ml or below, or 15 ng/ml or below if taking 5-alpha reductase inhibitor medicine
- Fits into the low, intermediate, or high risk group described by the trial
Who may not be able to
- Another cancer in the last 2 years (apart from some skin cancers), unless it will not affect 5-year survival
- Previous radiotherapy to the pelvis
- Any previous active treatment for prostate cancer, except hormone therapy (ADT); men on active surveillance may still join
- Life expectancy of less than 5 years
- Hip replacements on both sides, or other implants that would badly affect CT (computed tomography) scans
- Medical conditions that would make radiotherapy unwise, such as inflammatory bowel disease or serious urinary symptoms
- Taking warfarin or having a bleeding problem that would make marker placement or surgery unsafe (aspirin, clopidogrel and DOAC blood thinners such as apixaban or rivaroxaban are allowed)
- Taking part in another treatment study for prostate cancer at the same time
What taking part involves
- • SABR (stereotactic ablative body radiotherapy) — a precise form of radiotherapy given in fewer, stronger doses than standard treatment. Further details about the treatment schedule are not stated — ask the trial team.
Time commitment: Not stated — ask the trial team about how many visits are needed and how long taking part lasts.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 136
- Started
- 2026-04-23
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for prostate adenocarcinoma
- • Phase2 - 136 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate adenocarcinoma
- • Male only
Where?
- • Belfast - Northern Ireland Cancer Centre (NICC)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
What the study is looking for
- ✓Written agreement to take part 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...
- ✓Gleason score ≤ 4+3
Who cannot take part
- ✗Previous cancer within the last 2 years (except basal cell carcinoma (BCC) or squamous carcinoma of the skin),...
- ✗Prior pelvic radiotherapy
- ✗Any prior active treatment for prostate cancer (with the exception of ADT). Patients previously on active...
- ✗Life expectancy \<5 years.
- ✗Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
See the full criteria
Where Is This Study? (1 UK site)
Northern Ireland Cancer Centre (NICC)
Belfast BT9 7AB, United Kingdom
How to Get in Touch
Cancer Trials Ireland
Sponsor contactCONTACT