Prostate cancer study aims to find gentler radiation option
NCT ID NCT07210502
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares the side effects of two radiation treatments for men with low-to-intermediate risk prostate cancer: low dose rate brachytherapy (radioactive seeds placed in the prostate) and ultra-hypofractionated radiotherapy (5 sessions of external radiation over 2 weeks). Both treatments use a protective gel to shield the rectum. 220 men will be randomly assigned to one of the two treatments and followed for 5 years to see which causes fewer urinary, bowel, and sexual side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Men aged ≥18 years at randomisation * The research subject must have capacity to sign a written informed consent document for the trial * WHO performance status 0 - 2 * Gleason score 3+3 or 3+4 * PSA ≤ 20 ng/ml (please note if the treating clinician determines androgen deprivation therapy (ADT) is required this is an exclusion criteria). A PSA must be available within 60 days of randomisation. * Clinical and/or MRI stage T1c -T2c, N0-X, M0-X * Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance). Patients who were on active surveillance should have an up-to-date MRI within 8 weeks of the decision to treat to confirm organ confined disease. Exclusion Criteria: * Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 10-year survival. * Patients under investigation for synchronous primary at time of randomisation * Prior pelvic radiotherapy. * Prior treatment with ADT or current need for ADT based on risk features * Prostate cancer in greater than 50% of template biopsy cores or a significant maximum core length containing prostate cancer for which the treating clinician deems the patient would benefit from ADT * Any prior active treatment for prostate cancer (patients previously on active surveillance are eligible if they meet all other eligibility criteria) * Life expectancy \< 10 years Men with a prostate gland larger than 60 cc, or those with a large median lobe• Hip prostheses or any other implants/hardware that introduce substantial CT artefacts making it challenging to delineate the target or organs at risk. This is to be assessed on a case-by-case basis with the available staging imaging. * Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms. * International Prostate Symptom Score (IPSS) \> 15 points * Anticoagulation with warfarin/ bleeding tendency making fiducial placement, spacer gel insertion or brachytherapy unsafe in the opinion of the clinician * Contraindications for Barrigel insertion such as previous documented allergic reaction to gel, previous rectal surgery or known rectal fistula. * Participation in another concurrent treatment protocol for prostate cancer.
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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 places running it
1 site. 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
Locations
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Royal Surrey NHS Foundation Trust
Guildford, Surrey, GU2 7XX, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?