Actively Recruiting
Clinical Trial of Targeted Alpha Therapy Using [At-211]PSMA-5 for Prostate Cancer
Led by Osaka University · Updated on 2025-07-31
15
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
O
Osaka University
Lead Sponsor
J
Japan Agency for Medical Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of Targeted Alpha Therapy Using [At-211]PSMA-5 for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with progressive castration-resistant prostate cancer showing increased PSA levels or new tumor growth
- Patients with serum testosterone at castration level (< 50 ng/dL)
- Patients resistant to or not indicated for standard treatments including androgen receptor signaling inhibitors and taxane-based chemotherapy
- Patients aged 18 years or older
- Patients with stable general condition and ECOG performance status 0 to 2
- Patients expected to survive 6 months or more
- Patients without or with controlled symptomatic brain metastases
- Patients with no significant abnormal findings in electrocardiogram, respiratory rate, and blood oxygen saturation within 30 days before enrollment
- Patients with laboratory values within protocol-specified range within 30 days before enrollment
- Patients able to use appropriate contraception during the trial
- Patients who have given informed consent after understanding the trial procedures
You will not qualify if you...
- Patients who received systemic antitumor therapy (excluding androgen receptor signaling inhibitors) within 4 weeks before enrollment
- Patients who received radium chloride (223Ra) or 177Lu-PSMA-617 within 6 months before registration
- Patients currently receiving other cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitors, or AKT inhibitors
- Patients with active double cancer diagnosed within the past 5 years
- Patients who received other investigational drugs within 5 weeks prior to enrollment
- Patients with uncontrollable active infections
- Patients positive for Hepatitis B surface antigen, Hepatitis C antibody (unless HCV-RNA is undetectable), or HIV antibody
- Patients with mental illness or psychiatric symptoms that hinder trial participation
- Patients judged inappropriate for the trial by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Actively Recruiting
Research Team
T
Tadashi Watabe, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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