Could a stronger first dose of targeted radiation beat back advanced prostate cancer?

NCT ID NCT07682649

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

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

Anyone

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: * 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.

  1. The places running it

    1 site. 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

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

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