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New radioactive drug targets Hard-to-Treat prostate cancer

NCT ID NCT07381582

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new radioactive drug, 161Tb-LNC1011, in 15 men with advanced prostate cancer that no longer responds to hormone therapy. The drug is designed to seek out and deliver radiation directly to cancer cells. The main goals are to check safety and find the best dose, while also seeing if it can shrink tumors or lower PSA levels.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

Male participants only

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: * Male, ≥18 years. * Pathologically confirmed mCRPC per PCWG3. * 68Ga-PSMA-11 PET/CT positive. * Prior exposure to at least one novel androgen-axis drug (e.g., enzalutamide and/or abiraterone) or at least one taxane regimen, or intolerance/refusal to taxane chemotherapy. * ECOG 0-2; life expectancy ≥6 months. * Adequate organ function: ALT/AST ≤3× ULN; BUN/Cr ≤1.5× ULN; WBC ≥3.5×10\^9/L; PLT ≥100×10\^9/L; Hb ≥90 g/L. * Signed informed consent and willingness to comply with study procedures. Exclusion Criteria: * Major trauma/surgery within 4 weeks prior to study treatment. * Active severe systemic or localized infection or other serious comorbidity. * Immunodeficiency or recent use of immunosuppressants/immunoenhancers, recent vaccines. * Autoimmune diseases (e.g., rheumatoid arthritis) requiring active management. * Uncontrolled arrhythmias (incl. Afib), heart failure NYHA \> II, uncontrolled hypertension. * Known allergy to components of investigational product. * Positive syphilis, HBV/HCV/HIV. * Inadequate contraception in patients of reproductive potential. * Psychiatric illness compromising compliance. * Unable to undergo SPECT/CT or to retain urine for 30 minutes. * Any condition deemed unsuitable by the investigator.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Mianyang Central Hospital

    Mianyang, Sichuan, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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