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New radiation technique aims to spare the urethra in prostate cancer treatment

NCT ID NCT05804318

Disease control Sponsor: Varian, a Siemens Healthineers Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This trial is testing a daily adaptive radiation therapy for low to intermediate risk prostate cancer that spares the urethra. The goal is to reduce urinary side effects compared to standard radiation. About 132 participants will receive this tailored radiation, and their urinary quality of life will be tracked.

What this could mean

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

Active substance
daily adaptive stereotactic body radiation therapy (SBRT) with urethral sparing
What this could lead to
If successful, this approach could reduce urinary side effects during radiation for prostate cancer, making treatment more tolerable.
What could go wrong
This is an early-phase trial with no control group, so results may not confirm benefit. The approach is complex and may not work for all patients.

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 132 people

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

Started

Apr 2023

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven. 2. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy. 3. AUA/IPSS score is ≤ 15. 4. ECOG performance status is ≤2 (or Karnofsky score is ≥60%). 5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion). 6. Patient has the ability to complete required patient questionnaires. 7. Patient age ≥ 18 years (or greater than the local age of majority). 8. Patient has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patient has baseline grade ≥3 GI or GU toxicity 2. Patient has had prior overlapping pelvic radiotherapy. 3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation. 4. Patient has node positive prostate cancer. 5. Patient has extracapsular extension (capsular abutment is permitted). 6. Patient has active inflammatory bowel disease or active collagen vascular disease. 7. Patient cannot undergo prostate MRI. 8. Patient cannot undergo prostate fiducial marker placement. 9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

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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 places running it

    6 sites in 3 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

  • Brigham and Women's Hospital

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02115, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • Duarte Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Fox Chase Cancer Center

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Klinikum der Landeshauptstadt Stuttgart gKAöR

    RECRUITING

    Stuttgart, Baden-Wurttemberg, 70174, Germany

  • Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)

    RECRUITING

    Homburg, Saarland, 66421, Germany

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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