Weekly adaptive radiation aims to sharply target High-Risk prostate cancer
NCT ID NCT07591051
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
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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
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University Clinic Heidelberg
Heidelberg, Baden-Würtemberg, 69120, Germany
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University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
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Other studies related to the condition(s) this trial covers.
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