Actively Recruiting
Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by National Taiwan University Hospital · Updated on 2026-06-02
12
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 161Tb-PSMA-I&T, a new type of radioligand therapy using Terbium-161, in Taiwanese men with metastatic castration-resistant prostate cancer (mCRPC). This advanced form of prostate cancer no longer responds to hormone therapies and other treatments. The study aims to assess the safety, how the drug moves and distributes in the body, and its initial effectiveness compared to current treatments using Lutetium-177. The trial is a Phase I dose escalation study designed to inform future research and treatment strategies. Participants will receive one of three doses of 161Tb-PSMA-I&T (120, 150, or 200 mCi) administered by slow intravenous injection every six weeks for three cycles. The study will establish a production process for the therapy and monitor how it behaves in the body. Each dose level will be evaluated in sequence to determine safety and appropriate dosing for future trials. During the study, participants will undergo blood tests, imaging scans, and other assessments to monitor treatment effects and safety over at least 36 weeks. Researchers will track any treatment-related side effects and evaluate disease progression using specific imaging techniques and PSA levels. Patients will be monitored for organ function and overall health, with the study lasting until the post-treatment surveillance period concludes.
CONDITIONS
Brief Title
Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older, able to understand and willing to sign informed consent
- Histologically confirmed adenocarcinoma of the prostate with metastatic castration-resistant prostate cancer
- Prior surgical orchiectomy or chemical castration with serum testosterone <50 ng/dL
- Prior treatment with at least one line of taxane-based chemotherapy unless medically unsuitable
- Prior treatment with at least one line of androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide)
- Prior treatment with 177Lu-labeled PSMA radioligand therapy unless medically unsuitable or declined
- Progressive disease with rising PSA values or imaging showing soft tissue or bone progression
- Evidence of PSMA-avid lesions on 68Ga- or 18F-labeled PSMA PET/CT within 12 weeks prior to screening
- Life expectancy of at least 6 months and ECOG performance status 0-2
- Adequate bone marrow and organ function as defined by specific blood and kidney tests
- Willingness to use medically acceptable barrier contraception if sexually active
You will not qualify if you...
- History of allergic reaction to PSMA-targeted compounds or radiometals
- Prior radioligand therapy with 223Ra or 177Lu-PSMA within 6 months
- Prior surgery or radiotherapy within 4 weeks before first dose
- Prior systemic therapies against prostate cancer within 4 weeks including androgen receptor pathway inhibitors, chemotherapy, or PARP inhibitors
- Discordant disease on PET images with FDG-positive disease and minimal PSMA expression
- Untreated urinary tract obstruction causing hydronephrosis
- Known symptomatic brain metastases, leptomeningeal disease, or symptomatic/impending spinal cord compression unless treated
- Other active cancers needing systemic treatment
- Significant cardiovascular disease such as recent heart attack or unstable angina
- Severe uncontrolled illness including infections that may risk patient safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks
Participants receive 161Tb-PSMA-I&T radioligand therapy administered intravenously every 6 weeks for 3 cycles at one of three dose levels (120, 150, or 200 mCi) to target metastatic castration-resistant prostate cancer.
3 treatment visits every 6 weeks
Duration - At least 36 weeks
Participants are monitored for treatment-emergent adverse events and safety after completing the treatment cycles.
Periodic visits during post-treatment surveillance
Trial Site Locations
Total: 2 locations
1
National Taiwan University Cancer Center
Taipei, Taiwan
Actively Recruiting
2
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
P
Pei-Ju Chuang
C
Ching-Chu Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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