Weekly adaptive radiation aims to sharply target High-Risk prostate cancer

NCT ID NCT07591051

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 1 time

Summary

This study tests a weekly, image-guided radiation therapy (SBRT) for men with very high-risk prostate cancer that may have spread to nearby lymph nodes. The treatment uses weekly CT or MRI scans to adapt the radiation dose precisely to the tumor. The main goals are to see if this approach is feasible and safe, with 54 participants being followed for side effects and cancer control.

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 radiation therapy (SBRT) guided by CT or MRI scans
What this could lead to
If successful, this could offer a more precise and effective radiation treatment for men with very high-risk prostate cancer that has spread to nearby lymph nodes.
What could go wrong
This is a small, early feasibility study (54 people) testing a new way of delivering an established treatment. It may not prove better than standard approaches, and there is a risk of side effects like urinary or bowel problems.

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 54 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2033

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 include: * Regionally metastatic prostate cancer (cN1, any T, Gleason 6-10, any PSA) according to NCCN guidelines consisting of ≤ 5 regional lymph node metastases * Good to moderate performance status (WHO 0-2) * Written informed consent. * A PSMA PET and multiparametric MRI is mandatory according to staging guidelines. * Age ≥ 18 years Exclusion criteria include: * \>5 regional lymph nodes * Patients with cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall) * Previous radiotherapy to the pelvis or prostate * Previous radical prostatectomy * Large body size that would not fit into the MRI-simulator bore * Presence of distant metastases (i.e. cM1) * Non-regional lymph nodes (M1a): * Bone metastases (M1b) * Other sites (M1c) * Contraindications to CT or MR-adaptive SBRT (e.g., pacemakers, severe claustrophobia). * Severe comorbidities that may interfere with treatment or follow-up (e.g. inflammatory bowel disease). * Significant concomitant diseases (e.g. hepatic dysfunction, cardiovascular disease, etc.). * Inability to follow procedures or insufficient knowledge of project language, inability to give consent. * Participation in a clinical trial which might influence the results of this project. * Enrolment of the investigator, his/her family members, employees and other dependent persons. * Severe genitourinary or gastrointestinal symptoms (e.g. recent urinary retention or diarrhea ≥ grade 3 or obstipation to CTCAE v.6.0). * Severe urinary symptoms (e.g. IPSS \>12 and/or prostate volume \> 80 mL)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. 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 Clinic Heidelberg

    Heidelberg, Baden-Würtemberg, 69120, Germany

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8091, Switzerland

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