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Can a radioactive 'Smart Bomb' shrink resistant prostate tumors?

NCT ID NCT06441994

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called PSW-1025, which delivers a radioactive particle (astatine-211) directly to prostate cancer cells. The goal is to see if this targeted approach is safe and tolerable for men with castration-resistant prostate cancer, a form that no longer responds to standard hormone therapy. The study will also help determine the right dose for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a targeted alpha therapy drug called PSW-1025, which delivers astatine-211 to prostate cancer cells
What this could lead to
If successful, this could lead to a more precise treatment for advanced prostate cancer that is resistant to standard hormone therapy.
What could go wrong
This is an early phase 1 trial with only 15 participants, so safety and effectiveness are not yet known. There may be unforeseen side effects from the radioactive component.

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 15 people

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

Started

May 2024

Expected to finish

Mar 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: 1. Patients with progressive castration-resistant prostate cancer who meet the following conditions (1) and (2) (1) Patients with progressive increase of serum Prostate-Specific Antigen (PSA) (\>=2ng/mL, three consecutive increases at least one week apart, and two increases of more than 50% from the lowest value), or with the tumor growth or appearance of new lesions detected by imaging studies (2) Patients with the serum testosterone at castration level (\< 50ng/dL) 2. Patients who meet the following conditions (1) and (2), resistant to standard treatment or not indicated for the generally approved standard treatments (1) Patients who have received at least one of the following treatments * Inhibitors of androgen receptor signaling (enzalutamide, apalutamide, dalortamide, etc.) * Inhibitors of Cytochrome P450 17 (CYP 17) (abiraterone acetate) (2) Patients previously treated with the taxane-based chemotherapy (docetaxel or cabazitaxel) or not adapted for the taxane-based chemotherapy (including refusal cases)\* \* Targeting for the patients who have received cabazitaxel therapy after docetaxel therapy, or patients for whom cabazitaxel therapy was not indicated (including refusal cases) after docetaxel therapy, or patients for whom both docetaxel therapy and cabazitaxel therapy were not indicated (including refusal cases) 3. Patients aged 18 years or older at the time of consent acquisition 4. Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group) 5. Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings 6. Patients without or with controlled symptomatic brain metastases 7. Patients with no clinically significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before the enrollment 8. Patients whose laboratory values within 30 days before the enrollment are within the range specified in the protocol 9. Patients who can use appropriate contraception during the clinical trial period according to the protocol 10. Patients who thoroughly listened to the explanation of the clinical trial, agreed to the various study procedures outlined in the clinical trial protocol and signed the consent document Exclusion Criteria: 1. Patients who received systemic antitumor therapy (e.g. chemotherapy, immunotherapy, biologic therapy such as monoclonal antibodies, excluding androgen receptor signaling inhibitors) within 4 weeks before enrollment 2. Patients who received radium chloride (Radium, 223Ra) or 177Lu (Lutetium)-PSMA-617 within 6 months before registration 3. Patients currently receiving treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, AKT inhibitors 4. Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less) 5. Patients who received other investigational drugs within 5 weeks prior to enrollment 6. Patients with uncontrollable active infections 7. Hepatitis B surface antigen positive, Hepatitis C Virus antibody positive (patients with HCV-RNA level below the limit of detection can be registered) or Human Immunodeficiency Virus antibody positive patients 8. Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate in clinical trials 9. Other patients who are judged to be inappropriate by the investigator, etc.

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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.

Contacts and locations

Locations

  • Osaka University Hospital

    Suita, Osaka, 565-0871, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.