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New trial tests faster radiation for prostate cancer relapse

NCT ID NCT06523634

Disease control Sponsor: Jules Bordet Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a shorter, high-dose radiation treatment (SBRT) to standard radiation for men whose prostate cancer has come back after surgery. About 284 men will be randomly assigned to one of the two approaches. The goal is to see if SBRT is as safe and effective, with fewer side effects on bowel and urinary function.

What this could mean

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

Active substance
Stereotactic body radiotherapy (SBRT)
What this could lead to
If successful, this could offer a shorter, more convenient radiation option for men with prostate cancer recurrence after surgery, with similar or better quality of life.
What could go wrong
This is a phase II/III trial, so results are not yet confirmed. SBRT may cause different side effects, and it may not control the cancer as well as standard radiation in the long term.

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 284 people

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

Started

Dec 2024

Expected to finish

Feb 2032

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 1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent. 2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA \>0.1 ng/mL , or three consecutive PSA rises) 3. WHO PS 0-1 4. Age ≥18 years 5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry 6. Ability to understand and answer the EPIC-26 form in one of the languages available EXCLUSION CRITERIA 1. Patients with a pT4 tumor at prostatectomy 2. Patients with previously pathologically confirmed N1 3. Patients with macroscopically involved margin at surgery (R2) 4. Patients with a history of distant metastases 5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter \>1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence. 6. Latest PSA \> 2ng/ml 7. Patients with a IPSS \>20 8. Gleason 10 tumor 9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate 10. Prior pelvic radiotherapy 11. Prior hormonal therapy started more than 6 weeks before randomization 12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery. 13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • AZ Groeninge

    RECRUITING

    Kortrijk, Belgium

  • AZ Sint Jan

    RECRUITING

    Bruges, Belgium

  • AZ Sint-Maarten

    RECRUITING

    Mechelen, Belgium

  • AZorg

    RECRUITING

    Aalst, Belgium

  • CHU HELORA - Hôpital de La Louvière - site Jolimont

    RECRUITING

    La Louvière, Belgium

    Contact Email: •••••@•••••

  • CHU UCL Namur - Site Elisabeth

    RECRUITING

    Namur, Belgium

  • Cliniques universitaires Saint-Luc (UCLouvain)

    RECRUITING

    Woluwe-Saint-Lambert, Belgium

    Contact Email: •••••@•••••

  • Jessa Ziekenhuis

    RECRUITING

    Hasselt, Belgium

    Contact Email: •••••@•••••

  • Jules Bordet Institute, H.U.B

    RECRUITING

    Brussels, Belgium

  • UZ Gent

    RECRUITING

    Ghent, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • Ziekenhuis Aan de Stroom (ZAS)

    RECRUITING

    Antwerp, Belgium

  • Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan

    RECRUITING

    Genk, Belgium

    Contact Email: •••••@•••••

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