Smart scans may slash radiation doses for metastatic prostate cancer
NCT ID NCT07674771
First seen Jun 30, 2026 · Last updated Aug 25, 2026 · Updated 5 times
Summary
This early-phase trial explores whether PSMA PET scans can help doctors adjust radiation therapy for men with prostate cancer that has spread to 4 to 20 spots in the body. Participants receive standard hormone therapy plus a special PET scan, then targeted radiation to all visible tumors. A repeat scan after three radiation sessions may allow some tumors to skip the final two sessions if they show a complete response. The goal is to see if this adaptive approach can safely reduce the total radiation dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 68Ga-PSMA-11 and adaptive stereotactic ablative radiotherapy (SABR)
- What this could lead to
- If successful, this approach could reduce the amount of radiation needed for each tumor site, potentially lowering side effects while maintaining cancer control.
- What could go wrong
- This is a very early-phase trial with only 30 participants, so results may not apply broadly. The imaging and radiation technique may not shrink tumors as expected.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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: 1. History of pathologically confirmed prostate cancer. 2. Age \>=18 years. 3. Performance status ECOG 0-2. 4. Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within \<=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT). 5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR. 6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 7. Ability to understand and the willingness to sign a written informed consent. 8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2). Exclusion Criteria: 1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions. 2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded. 3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites. 4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study. 5. History of allergic reactions to PMSA-11 68Ga imaging agent. 6. Uncontrolled intercurrent illness or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
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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
1 site. 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 of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?