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Proton therapy may reduce bowel side effects after prostate cancer surgery

NCT ID NCT04083937

Disease control Sponsor: University Hospital Heidelberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of radiation therapy (proton vs. photon) given after prostate removal surgery. The goal is to see if proton therapy causes fewer bowel problems and improves quality of life. About 900 men with prostate cancer will be randomly assigned to one of the two radiation types.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiation therapy (proton or photon)
What this could lead to
If successful, this could show that proton therapy causes fewer bowel side effects than standard photon therapy after prostate surgery, improving quality of life without compromising cancer control.
What could go wrong
This is a large phase 3 trial, but results may not apply to all patients. The benefit of protons over photons may be small, and the shorter radiation schedule might not be as effective in the long run.

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 897 people

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

Started

Sep 2018

Expected to finish

Jan 2029

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: * histology-proven prostate cancer with Gleason Score and PSA-value; * indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy; * Karnofsky-Index ≥ 70% * age ≥ 18 years Exclusion Criteria: * androgen deprivation therapy * lymphatic spread * macroscopic tumor/ R2 * stage IV (M1) * previous irradiation

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

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