Could a stronger first dose of targeted radiation beat back advanced prostate cancer?
NCT ID NCT07682649
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether giving a higher first dose of the radioactive drug Lu-177-PSMA-617 can improve treatment for men with metastatic castration-resistant prostate cancer. The drug targets a protein on prostate cancer cells and delivers radiation to kill them. Researchers want to see if a stronger initial dose is safe and may work better than the standard six-dose schedule. The study enrolls about 20 men whose cancer has spread and no longer responds to hormone therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lu-177-PSMA-617 (radioactive drug)
- What this could lead to
- If successful, this approach could make radioligand therapy more effective for advanced prostate cancer by giving a higher dose early, potentially improving tumor control.
- What could go wrong
- This is a small, early-phase safety study (20 participants). The higher first dose may cause more side effects, and it is unknown if it will improve outcomes compared to the standard schedule.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2031
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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Anyone
- 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: * Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET/CT scan positive (lesion uptake \> liver uptake by visual assessment) * Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.) * Patients must be ≥18 years of age * Patients must have an ECOG performance status of 0 or 1 * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 * Platelet count ≥ 150,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Estimated glomerular filtration rate (EGFR) ≥ 60ml/min * Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases * Albumin \> 3.0 g/dL * Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Does not meet criteria for standard Lu-177-PSMA-617 RLT * Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician * Prior RLT * Unmanageable concurrent bladder outflow obstruction or urinary incontinence * Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation * Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy * Exclusion criteria for participation in other investigational trials: should not participate during RLT or 30 days prior to start of RLT
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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 Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Mapping radiation dose in real time: a smarter way to treat prostate cancer?
- Can a tracer that hunts unstable iron light up hidden tumors?
- Can a three-drug cocktail outsmart resistant prostate cancer?
- Precision radiation may tame rising PSA after prostate surgery
- Blood test could tell doctors when to stop prostate cancer treatment early