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Can precision protons spare the bowel in prostate cancer?

NCT ID NCT05350475

Disease control Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether proton therapy, a more precise form of radiation, causes fewer long-term bowel side effects than standard photon therapy in men with high-risk prostate cancer. Participants receive the same radiation dose and schedule, but one group gets protons and the other photons. The study tracks bowel, urinary, and sexual side effects over two to five years to see if protons improve 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
Proton therapy compared to standard photon radiation therapy
What this could lead to
If protons reduce long-term bowel side effects, this could establish proton therapy as a better standard for high-risk prostate cancer, improving quality of life.
What could go wrong
The trial is relatively small and early, and results may not show a significant difference. Proton therapy may not be widely available or cost-effective.

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 102 people

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

Started

Mar 2022

Expected to finish

Dec 2038

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 years and older

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: * Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck. * Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%) * Indication for elective lymph node irradiation * PSA \< 100 ng/mL * Age ≥18 years * Performance status 0-1 * Life expectancy ≥ 10 years * Able to understand and comply with the treatment protocol * No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up * Signed informed consent to participate in the study Exclusion Criteria: * No previous treatment for prostate cancer * Hip-prostheses * Other metal devices in the pelvic region (except fiducials) * Previous major abdominal/rectal surgery * Any other malignancy the last five years except for basal or squamous cell skin cancer * Unable to understand patient information or comply with treatment and safety instructions * Unable to read and understand patient information due to cognitive disabilities or language (Danish).

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Conditions

The condition(s) this trial relates to.

prostate cancer radiation injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer Radiotherapy side effect

Contacts and locations

Locations

  • Department of Oncology, Aarhus University Hospital

    Aarhus, Central Region, 8200, Denmark

  • Department of Oncology, Copenhagen University Hospital Herlev

    Herlev, Capital Region, DK-2730 Herlev, Denmark

  • Department of Oncology, Odense University Hospital

    Odense, Region South, 5000, Denmark

  • Department of Oncology, Vejle Hospital, Denmark

    Vejle, Region South, Denmark

  • Dept. of Oncology, Aalborg University Hospital

    Aalborg, Region North, Denmark

  • Dept. of Oncology, Rigshospitalet, Denmark

    Copenhagen, Capital Region, Denmark

  • Dept. of Oncology, Zealand University Hospital, Denmark

    Næstved, Region Sjælland, Denmark

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