Clinical Trial of Targeted Alpha Therapy Using [At-211]PSMA-5 for Prostate Cancer

NCT06441994 | Recruiting Phase 1

• 1 other identifier: APS1-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Astatine (At-211); Targeted alpha therapy; PSMA (Prostate Specific Membrane Antigen)

Outcome Measures

Primary Outcomes (2)

• Treatment-related adverse events as assessed by CTCAE v5.0

  until 6 months after administration

• Dose Limiting Toxicity

  within 4 weeks after single administration

Secondary Outcomes (10)

• Number of participants with adverse events and their details

  until 6 months after administration

• Blood pressure (mmHg) and heart rate (bpm)

  until 6 months after administration

• Symptoms of the participants

  until 6 months after administration

• Hematological tests (blood cell counts)

  until 6 months after administration

• Urine tests (occult blood and urine protein)

  until 6 months after administration

Study Arms (1)

Administration arm

EXPERIMENTAL

Drug: PSW-1025

Interventions

PSW-1025 DRUG

PSMA (prostate specific membrane antigen)-targeted alpha therapy drug labeled with Astatine (At-211)

Administration arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Osaka University: lead
• Japan Agency for Medical Research and Development: collaborator

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Tadashi Watabe, M.D., Ph.D.

CONTACT

+81-6-6879-3434; watabe.tadashi.med@osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 4, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)