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One-Shot radiation may tame returning prostate cancer

NCT ID NCT07635108

Disease control Sponsor: Odense University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single, powerful dose of MRI-guided radiation can safely treat prostate cancer that has come back in a few lymph nodes after initial treatment. Forty-eight men will receive one 24 Gy radiation session aimed precisely at the affected nodes. The main goal is to check for severe side effects, while also seeing if the treatment controls the cancer and delays the need for hormone therapy.

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 (single high-dose MR-guided stereotactic body radiotherapy)
What this could lead to
If successful, this could offer a way to control prostate cancer that has returned in a few lymph nodes, potentially delaying the need for hormone therapy and its side effects.
What could go wrong
This is a small, early-phase trial with only 48 participants, so results may not apply to everyone. The treatment involves high-dose radiation, which carries risks of severe side effects.

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 48 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2035

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: * Age ≥ 18 years * Signed informed consent * Histologically proven initial diagnosis of adenocarcinoma of the prostate * ECOG performance status 0-2 * Biochemical recurrence after curatively intended local treatment (radical prostatectomy and/or radiotherapy), with PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen * Any additional sites of disease beyond the protocol-specified target lymph nodes must be considered suitable for ablative treatment * Life expectancy \> 6 months * Lymph node size ≤ 2 cm Exclusion Criteria: * Medical contraindications to MRI * Inability to tolerate the physical set-up required for SABR * Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury * Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease) * Uncontrolled intercurrent illness

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Conditions

The condition(s) this trial relates to.

Lymphatic Metastasis metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Nodal oligorecurrent prostate cancer Oligo-metastatic prostate carcinoma Oligometastatic cancer 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

  • Department of Oncology, Odense University Hospital

    Odense, Denmark

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