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Targeted radiation aims to cure prostate cancer while sparing healthy tissue
NCT ID NCT06080113
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers in Denmark are testing a targeted radiation technique called focal brachytherapy for men with early prostate cancer. The treatment places radioactive sources directly into the tumor, guided by MRI and ultrasound, to destroy cancer while leaving the rest of the prostate untouched. The trial follows 50 men for up to 10 years to track cancer control, side effects, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- focal brachytherapy, a targeted radiation treatment that places radioactive sources directly into the tumor
- What this could lead to
- If it works, this approach could offer men with early prostate cancer a curative treatment that preserves healthy tissue and reduces side effects like incontinence and erectile dysfunction.
- What could go wrong
- The trial is small and early, so it may not show that focal brachytherapy controls cancer as well as standard whole-gland treatment. Some men may need additional treatment if cancer returns.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jun 2037
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 to 80 years
- 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: * Age 40-80; Performance status 0-1; \>10 yr. life expectancy * Candidate for curative intended treatment * PSA \<20 ng/mL * Clinical stage T1c or T2a * Prostate anatomy suitable for focal brachytherapy * MRI identified index tumour (PI-RADS 3-5) with PCa confirmed on biopsy * A single index tumour focus with Gleason score 6 (\>10 mm maximum cancer-core length \[MCCL\]), Gleason score 3+4 (any MCCL) or Gleason core 4+3 (\<10 mm MCCL) * Systematic biopsies (≥10-12 cores) with no or low volume Gleason score 6 (3+3) PCa only * No severe urinary obstructive symptoms (e.g., urinary retention needing indwelling catheter) * Fit to undergo all procedures in the protocol * Included subjects should be able to participate in the planned follow-up (either on-site visits or telephone consultation accepted at specific time-points). * Included subjects should be able to read and understand the study details, and provide written informed consent to participate Exclusion Criteria: If any of the following criteria is present, the subject cannot participate in the study: * Not a candidate for curative intended treatment (e.g., other active malignancy except for non-melanoma skin-cancer, life-expectancy \<10 years, severe comorbidities etc.) * Prior surgical or radiation treatment of PCa; Prior transurethral-resection (TUR-P) is not an exclusion criterion. * Evidence/suspicion of extra prostatic extension on MRI * Tumour focus \>50% of one prostate half on MRI corresponding to stage \>T2a * Briganti 2018 score ≥7% * PCa with intraductal carcinoma, cribriform pattern, or small cell component * Any anatomical or clinical conditional not suitable for brachytherapy (e.g., imperforate anus, prostatitis, inflammatory bowel disease, severe calcifications etc.) * Any contraindication for prostate MRI (e.g., claustrophobia, pacemaker, estimated glomerular filtration rate ≤30 mL/min/1.73m2) * Reduction in MRI image quality that interferes with diagnosis caused by e.g., hip replacement surgery or other metal implants in the pelvic area. * Any medical condition precluding procedures * Any medication that may alter prostate morphology or alter MRI appearance (e.g., 5-alpha reductase inhibitors, prior androgen deprivation therapy \[ADT\]) * Subjects who are unwilling or unable to adhere to the study requirements (including treatment, required assessments and follow-up).
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Department of Urology, Herlev University Hospital Herlev
Herlev, 2730, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?