NCT07621692 Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T
| NCT ID | NCT07621692 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Taiwan University Hospital |
| Condition | Metastatic Castration Resistant Prostate Cancer (mCRPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a phase I dose escalation clinical trial aims to evaluate 161Tb-PSMA-I\&T, a new generation prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) using Terbium-161 to replace Lutetium-177, its safety, dosimetry, biodistribution, pharmacokinetics, and preliminary efficacy in Taiwanese men with metastatic castration-resistant prostate cancer, and to inform future clinical trials.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 20 years, ability to understand and willingness to sign informed consent, cooperate with all study-related procedures and assessments including blood tests and imaging 2. Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC) 3. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone analog, with a serum testosterone level \<50 ng/dL (castrate range) 4. Prior treated with at least one line of taxane-based chemotherapy unless medically unsuitable, and at least one line of androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) 5. Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient 6. Progressive disease defined according to Prostate Cancer Clinical Trials Working Group 3: Either a PSA progression of more than 2 rising PSA values from baseline with intervals ≥ 1 week, or a soft-tissue progression on images per RECIST 1.1 criteria, or a bone progression on images with more than 2 new lesions 7. Evidence of significant PSMA-avid lesions on 68Ga- or 18F-labeled PSMA PET/CT within 12 weeks prior to screening, which defined as 68Ga-PSMA or 18F-PSMA uptake greater than that of liver or spleen parenchyma (depend on the tracer used) in at least one metastatic lesion of any size in any organ system 8. A life expectancy of ≥ 6 months and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 9. Adequate bone marrow and organ functions 9.1 Hemoglobin ≥ 10 g/dL without RBC transfusion within 4 weeks 9.2 Absolute neutrophil count ≥ 1.5 × 109/L 9.3 Platelet count ≥ 150 × 109/L 9.4 Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault) 9.5 AST and ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN 10. Willingness to comply with the use of medically acceptable forms of barrier contraception if sexually active Exclusion Criteria: 1. History of allergic reaction to PSMA-targeted compounds or radiometals 2. Prior radioligand therapy with 223Ra or 177Lu-PSMA within 6 months 3. Prior surgery or radiotherapy within 4 weeks prior to first investigational dose 4. Prior systemic therapies against prostate cancer within 4 weeks, including androgen receptor pathway inhibitor, chemotherapy, targeted therapy such as PARP inhibitors (PARPi) 5. Discordant disease on PET images: FDG-positive disease with minimal PSMA expression 6. Urinary tract obstruction causing hydronephrosis unless appropriately treated beforehand 7. Known symptomatic brain metastases or leptomeningeal disease, symptomatic or impending cord compression unless appropriately treated beforehand 8. Other active malignancy requiring systemic treatment 9. Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina) 10. Concurrent severe uncontrolled illness that may jeopardize patient safety, including uncontrolled infections
Contact & Investigator
Ching-Chu Lu
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT07621692 clinical trial?
This trial is open to male participants only, aged 20 Years or older, studying Metastatic Castration Resistant Prostate Cancer (mCRPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07621692 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07621692 currently recruiting?
Yes, NCT07621692 is actively recruiting participants. Contact the research team at pjchuang.ntucc@gmail.com for enrollment information.
Where is the NCT07621692 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT07621692 clinical trial?
NCT07621692 is sponsored by National Taiwan University Hospital. The principal investigator is Ching-Chu Lu at National Taiwan University Hospital. The trial plans to enroll 12 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.