Prostate CancerPhase 1Alpha-PS1NCT06441994
Clinical Trial of Targeted Alpha Therapy Using [At-211]PSMA-5 for Prostate Cancer
A Phase 1 study testing PSW-1025 in people with Prostate Cancer, run by Osaka University at 1 site in Japan.
Trial summary
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSW-1025
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- 24 May 2024to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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)
- Patients aged 18 years or older at the time of consent acquisition
- Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
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- Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
- Patients without or with controlled symptomatic brain metastases
- Patients with no clinically significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before the enrollment
- Patients whose laboratory values within 30 days before the enrollment are within the range specified in the protocol
- Patients who can use appropriate contraception during the clinical trial period according to the protocol
- 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
Who cannot join
- 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
- Patients who received radium chloride (Radium, 223Ra) or 177Lu (Lutetium)-PSMA-617 within 6 months before registration
- Patients currently receiving treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, AKT inhibitors
- Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
- Patients who received other investigational drugs within 5 weeks prior to enrollment
- Patients with uncontrollable active infections
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- 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
- Patients with mental illness or psychiatric symptoms who are judged to be difficult to participate in clinical trials
- Other patients who are judged to be inappropriate by the investigator, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Investigator-initiated Clinical Trial of a Novel Targeted Alpha Therapy Using [At-211]PSMA-5 for Patients With Castration-resistant Prostate Cancer
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II.
Read the detailed description
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II. PSW-1025 ([At-211]PSMA-5) is an alpha-ray-emitting drug labeled with Astatine (At-211) that targets PSMA (Prostate Specific Membrane Antigen).
- Conditions
- Prostate Cancer
- Being tested
- PSW-1025
- Keywords
- Astatine (At-211), Targeted alpha therapy, PSMA (Prostate Specific Membrane Antigen)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSW-1025Drug
PSMA (prostate specific membrane antigen)-targeted alpha therapy drug labeled with Astatine (At-211)
| Study group | Role | What they receive |
|---|---|---|
| Administration arm | Experimental | Not described Receives: Drug: PSW-1025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events as assessed by CTCAE v5.0
Measured: until 6 months after administration
Dose Limiting Toxicity
Measured: within 4 weeks after single administration
Secondary outcomes (10)
Number of participants with adverse events and their details
Measured: until 6 months after administration
Blood pressure (mmHg) and heart rate (bpm)
Measured: until 6 months after administration
Symptoms of the participants
Measured: until 6 months after administration
Hematological tests (blood cell counts)
Measured: until 6 months after administration
Urine tests (occult blood and urine protein)
Measured: until 6 months after administration
Electrocorticogram
Measured: until 6 months after administration
Prostate-Specific Antigen (PSA) (ng/ml)
Measured: until 6 months after administration
Tumor size on CT (mm)
Measured: until 6 months after administration
Excretion rates in urine, feces, and breath (%injected dose)
Measured: until 24 hours after administration
Absorbed doses in major organs (Gy)
Measured: until 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start24 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Responsible party
- Principal investigator, Tadashi Watabe, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441994
- Sponsor's protocol ID
- APS1-001
- Acronym
- Alpha-PS1
- Status last verified
- Jul 2026
- First submitted
- 26 May 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Investigator-initiated Clinical Trial of a Novel Targeted Alpha Therapy Using [At-211]PSMA-5 for Patients With Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06441994
- Acronym / sponsor ID
- Alpha-PS1 / APS1-001
- Conditions
- Prostate Cancer
- Keywords
- Astatine (At-211), Targeted alpha therapy, PSMA (Prostate Specific Membrane Antigen)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Japan Agency for Medical Research and Development
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II.
Detailed description
PSW-1025 is administered intravenously to patients with castration-resistant prostate cancer to evaluate its tolerability, safety, pharmacokinetics, absorbed dose, and efficacy, as well as to determine the recommended dose for Phase II. PSW-1025 ([At-211]PSMA-5) is an alpha-ray-emitting drug labeled with Astatine (At-211) that targets PSMA (Prostate Specific Membrane Antigen).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration arm | Experimental | Drug: PSW-1025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- 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
- Patients aged 18 years or older at the time of consent acquisition
- Patients with stable general condition with PS (Performance status) of 0 to 2 in ECOG (Eastern Cooperative Oncology Group)
- Patients who can be expected to survive for 6 months or more, judging from clinical symptoms and medical examination findings
Key exclusion criteria (9 listed)
- 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
- Patients who received radium chloride (Radium, 223Ra) or 177Lu (Lutetium)-PSMA-617 within 6 months before registration
- Patients currently receiving treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, AKT inhibitors
- Patients with active double cancer (simultaneous double cancer and ectopic double cancer with a disease-free period of 5 years or less)
- Patients who received other investigational drugs within 5 weeks prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSW-1025PSMA (prostate specific membrane antigen)-targeted alpha therapy drug labeled with Astatine (At-211) | Drug | Administration arm |
Primary outcome
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: until 6 months after administration
Dose Limiting Toxicity
Time frame: within 4 weeks after single administration
10 secondary outcomes
Number of participants with adverse events and their details
Time frame: until 6 months after administration
Blood pressure (mmHg) and heart rate (bpm)
Time frame: until 6 months after administration
Symptoms of the participants
Time frame: until 6 months after administration
Hematological tests (blood cell counts)
Time frame: until 6 months after administration
Urine tests (occult blood and urine protein)
Time frame: until 6 months after administration
Electrocorticogram
Time frame: until 6 months after administration
Prostate-Specific Antigen (PSA) (ng/ml)
Time frame: until 6 months after administration
Tumor size on CT (mm)
Time frame: until 6 months after administration
Excretion rates in urine, feces, and breath (%injected dose)
Time frame: until 24 hours after administration
Absorbed doses in major organs (Gy)
Time frame: until 24 hours after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PSW-1025 in people with Prostate Cancer, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events as assessed by CTCAE v5.0 (time frame: until 6 months after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.