Can a radioactive 'Smart Bomb' shrink resistant prostate tumors?
NCT ID NCT06441994
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
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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 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Mar 2027
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: 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
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Osaka University Hospital
Suita, Osaka, 565-0871, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?