New hope for men with spread prostate cancer: targeted radiation may boost standard care
NCT ID NCT06150417
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 8 times
Summary
This study is for men with prostate cancer that has spread to a few other parts of the body at diagnosis. It tests whether adding radiation therapy directly to those cancer spots (called metastasis-directed radiotherapy) can help keep the cancer under control longer than the usual treatment of hormone therapy and prostate radiation alone. About 200 men will take part, receiving standard care plus either extra radiation or not. The goal is to see if the extra radiation delays cancer progression.
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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 200 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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Dec 2028
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: * Participant must be ≥ 18 years of age. * Participant must have an ECOG performance status ≤ 1. * Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT. Biopsy of sites of metastasis is strongly encouraged, but not required. * There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available. * Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease. * Participants may have started LHRH agonist or antagonist therapy, and/or androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study. * In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and/or extra-pelvic lymph node (LN) stations. * Extra-pelvic LN stations are superior to the regional/pelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins. * Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and/or heterogeneous morphology * In participants who undergo PSMA PET/CT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and/or extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation * In participants extra-pelvic nodal (M1a) disease only by PSMA PET/CT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible: * 1\. PSA ≥ 40 * 2\. Evidence of cN1 disease (pelvic LN) * 3\. Decipher score ≥ 0.89 * Adequate organ and marrow function to receive treatment per treating physician * Medically fit for treatment and agreeable to follow-up. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Participants with the presence of any of the following: * Castration resistant prostate cancer (CRPC). * Evidence of visceral or intracranial metastases. * Participant receiving any other investigational agents for cancer. * Participant is participating in a concurrent treatment protocol for cancer. * Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT. * Prior definitive treatment to the primary prostate cancer or pelvis. * Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \> 10), active pituitary or adrenal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements * History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence * Active Crohn's disease or ulcerative colitis despite medical management. * Refusal to sign informed consent. * Any condition that in the opinion of the investigator would preclude participation in this study
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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
3 sites. 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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Carbone Cancer Center University of Wisconsin-Madison
RECRUITINGMadison, Wisconsin, 53792, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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University Hospitals Cleveland Medical Center Seidman Cancer Center
RECRUITINGCleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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