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Can proton beams spare prostate cancer patients from side effects?

NCT ID NCT02766686

Disease control Sponsor: Technische Universität Dresden 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial compares two types of radiation therapy for prostate cancer: proton therapy and standard photon therapy. The main question is whether proton therapy reduces moderate to severe urinary or intestinal side effects. Researchers will also track quality of life, cancer recurrence, and survival. The study enrolls men with localized prostate cancer who have a life expectancy of at least 10 years.

What this could mean

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

Active substance
Radiotherapy with protons or photons
What this could lead to
If proton therapy proves better, it could become a preferred treatment for prostate cancer, offering fewer side effects and better quality of life for patients.
What could go wrong
The trial is not randomized, so results may be biased. Proton therapy may not significantly reduce side effects compared to modern photon techniques, and it is more expensive.

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

180 people

The number who actually took part.

Start date

Sep 2016

Finished

Aug 2026

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: * life expectancy ≥ 10 years * adenocarcinoma of the prostate confirmed by punch biopsy * locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. T1-3b N0-1 M0 * stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months) * good general condition (ECOG performance status 0 - 1) * marker seed implantation before irradiation (optional) or possibility of Image-guided Radiation Therapy (IGRT) by CT * adequate compliance for follow-up * written informed consent Exclusion Criteria: * distant metastases * previous radiotherapy of the lesser pelvis * previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer * participation in another clinical study, if it's excluded by the study protocols

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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

Contacts and locations

Locations

  • Klinikum rechts der Isar, Technische Universität München

    Munich, 81675, Germany

  • University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology

    Dresden, 01307, Germany

  • Universitätsklinik für Radioonkologie, Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

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