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Targeted radiation aims to cure prostate cancer while sparing healthy tissue

NCT ID NCT06080113

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2037

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Department of Urology, Herlev University Hospital Herlev

    Herlev, 2730, Denmark

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