New radiation approach aims to tame prostate cancer with fewer side effects
NCT ID NCT07552168
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests a next-generation radiation therapy (SABR) for men with low to high-risk prostate cancer. The goal is to see if this advanced technique can control the cancer while reducing long-term side effects like urinary and bowel problems. About 136 participants will receive the treatment and be followed for up to 5 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2034
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Bon Secours - UPMC Hillman
RECRUITINGCork, T12 DV56, Ireland
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Northern Ireland Cancer Centre (NICC)
NOT_YET_RECRUITINGBelfast, Ulster, BT9 7AB, United Kingdom
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St Luke's Centre for Radiation Oncology at Beaumont Hospital
NOT_YET_RECRUITINGDublin, Leinster, D09 FT51, Ireland
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UPMC Hillman Cancer Centre at Whitfield Hospital
RECRUITINGWaterford, Ireland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?
- Can a better scan sharpen radiation for prostate cancer?
- Hormone therapy showdown: can an oral pill beat the shot for prostate cancer patients?
- Can tracking tumor movement during radiation make treatment more precise?