Precision radiation targets hidden prostate cancer spots
NCT ID NCT06392295
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving radiation to the para-aortic lymph nodes (located in the abdomen) can better control prostate cancer that has returned in a limited number of spots. Men with hormone-sensitive prostate cancer and up to five lesions seen on a PSMA PET/CT scan will receive daily radiation for five weeks, along with standard hormone therapy. The goal is to improve cancer control and maintain quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (photon or proton) to para-aortic and pelvic lymph nodes
- What this could lead to
- If successful, this approach could offer a more targeted way to control prostate cancer that has spread to lymph nodes, potentially delaying the need for stronger treatments.
- What could go wrong
- This is a small, early-phase trial (34 participants) and may not prove effective for everyone. Radiation to the abdomen carries risks such as fatigue, bowel or bladder irritation, and possible long-term 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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Aug 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. Histologically proven prostate adenocarcinoma 2. Male, ≥ 18 years old 3. Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes * a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) \> liver uptake and CT scan correlate) * b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes * c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes * d. Non-bulky nodal disease (ie, tumor \<5 cm) 4. Prior pelvic radiation with disease response * a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or * b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes 5. Hormone-sensitive prostate cancer 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 7. Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s) 8. Willingness to fill out quality of life and psychosocial forms 9. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767) Exclusion Criteria: 1. No pathological diagnosis of prostate adenocarcinoma 2. Patient has more than 5 sites of metastatic disease 3. Patient has history of bone and/or visceral metastasis 4. No evidence of disease in the para-aortic or pelvic lymph nodes 5. No staging with PSMA PET/CT scan 6. History of prior radiation therapy outside the pelvis for prostate cancer 7. Bulky nodal disease \>5 cm in tumor size 8. Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment 9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy 10. Implanted hardware which limits treatment planning or delivery (determined by treating physician) 11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \<50 ng/dL) 12. Patients with ECOG performance status \> 2 13. History of inflammatory bowel disease 14. History of malignancy other than prostate cancer except for non-melanoma skin cancer 15. Patients unable to consent or are prisoners 16. Unwilling to fill out quality of life and psychosocial forms 17. Participants with impaired decision-making capacity
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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 Miami
RECRUITINGMiami, Florida, 33136, 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?