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New hope for men with early spread prostate cancer: targeted radiation trial

NCT ID NCT05223803

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether adding precise, high-dose radiation to cancer spots outside the prostate (called metastases) can help men whose prostate cancer has spread to just a few places. About 122 men with up to 5 metastatic spots will receive standard treatment plus either observation or targeted radiation. The goal is to see if this approach delays cancer progression and improves survival without major 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 122 people

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

Started

Oct 2022

Expected to finish

Jul 2029

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. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan. 1. CT or MRI scan within 6 months of enrollment 2. Bone scan within 6 months of enrollment 3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan) 2. Histologic confirmation of malignancy (primary or metastatic tumor). 3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment. 4. PSA \> 0.5 but \<100. 5. Patient must be ≥ 18 years of age. 6. Patient must have a life expectancy ≥ 12 months. 7. Patient must have an ECOG performance status ≤ 2. 8. Patient must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Castration-resistant prostate cancer (CRPC). 2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy 3. Spinal cord compression or impending spinal cord compression. 4. Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis). 5. Patient receiving any other investigational agents. 6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist . 7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR. 8. No radiographical evidence of cranial metastasis. 9. Refusal to sign informed consent.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Oligometastatic disease 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

    10 sites. 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

  • Baltimore Washington Medical Center

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Bon Secours Cancer Institute at St. Francis

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • Central Maryland Radiation Oncology

    RECRUITING

    Columbia, Maryland, 21044, United States

  • KU Medical Center- Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Maryland Proton Treatment Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Sidney Kimmel Cancer Center at Jefferson Health

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • UMMC

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Upper Chesapeake Health

    RECRUITING

    Bel Air, Maryland, 21014, United States

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