Metastatic Castration Resistant Prostate Cancer (mCRPC)Phase 1NCT07621692
Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T
A Phase 1 study testing 161Tb-PSMA-I&T in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- What is being tested?
- 161Tb-PSMA-I&T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2030
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC)
- Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone analog, with a serum testosterone level <50 ng/dL (castrate range)
- 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)
- Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient
- 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
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- 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
- A life expectancy of ≥ 6 months and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- 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
- Willingness to comply with the use of medically acceptable forms of barrier contraception if sexually active
Who cannot join
- 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 prior to first investigational dose
- Prior systemic therapies against prostate cancer within 4 weeks, including androgen receptor pathway inhibitor, chemotherapy, targeted therapy such as PARP inhibitors (PARPi)
- Discordant disease on PET images: FDG-positive disease with minimal PSMA expression
- Urinary tract obstruction causing hydronephrosis unless appropriately treated beforehand
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- Known symptomatic brain metastases or leptomeningeal disease, symptomatic or impending cord compression unless appropriately treated beforehand
- Other active malignancy requiring systemic treatment
- Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina)
- Concurrent severe uncontrolled illness that may jeopardize patient safety, including uncontrolled infections
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei
Dr. Chuang, +886-2-2322-0322 ext. 237966, pjchuang.ntucc@gmail.com
- Recruiting
National Taiwan University Hospital
Taipei
Dr. Lu, +886-2-2312-3456 ext. 265477, kelvinlu@ntuh.gov.tw
About this study
Official title: 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
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.
Read the detailed description
Metastatic castration-resistant prostate cancer (mCRPC) represents the most advanced and treatment-refractory form of prostate cancer, where disease progression continues despite hormone-suppressing therapies and multiple lines of systemic treatment. Radioligand therapy (RLT) targeting prostate-specific membrane antigen (PSMA) has emerged as a promising treatment strategy, delivering targeted radiation to cancer cells using PSMA-binding ligands labeled with therapeutic radioisotopes. While Lutetium-177 (177Lu)-labeled compounds such as 177Lu-PSMA-617 have demonstrated meaningful clinical benefit, their effectiveness may be limited in cases of micrometastatic disease or heterogeneous PSMA expression, due to the physical characteristics of longer-range β particle radiation.
Terbium-161 (161Tb) is a next-generation radionuclide that emits not only β particles but also short-range, high-linear energy transfer Auger electrons. This dual emission profile enables more effective cell killing in small or poorly perfused tumor sites, with potentially enhanced tumor-to-normal tissue selectivity. Preclinical studies and early case reports suggest that 161Tb-labeled PSMA agents may offer superior tumor dosimetry and cytotoxicity compared to 177Lu analogs. Most notably, the recently published VIOLET Phase I/II trial-the largest clinical experience with 161Tb-PSMA-I\&T to date-demonstrated favorable safety across escalating doses (up to 7.4 GBq) and promising therapeutic activity. These findings confirm that 161Tb-PSMA RLT is both safe and clinically active, even in patients previously treated with 177Lu-based agents.
Building on this foundation, our study aims to establish a standardized GMP-grade production process for 161Tb-PSMA-I\&T and to evaluate its pharmacokinetics, biodistribution, and radiation dosimetry in a small cohort of Taiwanese patients with mCRPC. These pilot data will generate critical clinical insight and infrastructure, directly informing the design of future Phase Ib/II trials and accelerating national readiness for next-generation PSMA-targeted therapies, especially emphasizing on three specific aims: (1) to establish a GMP-compliant manufacturing process for clinical-grade 161Tb-PSMA-I\&T suitable for clinical application in Taiwan; (2) to characterize 161Tb-PSMA-I\&T focusing on its pharmacokinetics, biodistribution, and radiation dosimetry; (3) to explore preliminary safety data of 161Tb-PSMA-I\&T using potential treatment doses in Asian population.
- Being tested
- 161Tb-PSMA-I&T
- Keywords
- Radioligand therapy, Terbium-161, Prostate-specific Membrane Antigen (PSMA), Metastatic Castration Resistant Prostate Cancer (mCRPC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
161Tb-PSMA-I&TDrug
161Tb-PSMA-I\&T for injections, slow intravenous administration, 200 mCi/5 mL/Vial
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | 120 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles Receives: Drug: 161Tb-PSMA-I&T |
| Dose level 2 | Experimental | 150 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles Receives: Drug: 161Tb-PSMA-I&T |
| Dose level 3 | Experimental | 200 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles Receives: Drug: 161Tb-PSMA-I&T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 across the entire treatment and 18-week post-treatment surveillance period
Measured: From enrollment to the end of post-treatment surveillance, at least 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation with 3 dose levels
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Chu Lu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621692
- Sponsor's protocol ID
- 202507234MINB
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07621692
- Acronym / sponsor ID
- 202507234MINB
- Keywords
- Radioligand therapy, Terbium-161, Prostate-specific Membrane Antigen (PSMA), Metastatic Castration Resistant Prostate Cancer (mCRPC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Jun 2026 (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.
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.
Detailed description
Metastatic castration-resistant prostate cancer (mCRPC) represents the most advanced and treatment-refractory form of prostate cancer, where disease progression continues despite hormone-suppressing therapies and multiple lines of systemic treatment. Radioligand therapy (RLT) targeting prostate-specific membrane antigen (PSMA) has emerged as a promising treatment strategy, delivering targeted radiation to cancer cells using PSMA-binding ligands labeled with therapeutic radioisotopes. While Lutetium-177 (177Lu)-labeled compounds such as 177Lu-PSMA-617 have demonstrated meaningful clinical benefit, their effectiveness may be limited in cases of micrometastatic disease or heterogeneous PSMA expression, due to the physical characteristics of longer-range β particle radiation.
Terbium-161 (161Tb) is a next-generation radionuclide that emits not only β particles but also short-range, high-linear energy transfer Auger electrons. This dual emission profile enables more effective cell killing in small or poorly perfused tumor sites, with potentially enhanced tumor-to-normal tissue selectivity. Preclinical studies and early case reports suggest that 161Tb-labeled PSMA agents may offer superior tumor dosimetry and cytotoxicity compared to 177Lu analogs. Most notably, the recently published VIOLET Phase I/II trial-the largest clinical experience with 161Tb-PSMA-I\&T to date-demonstrated favorable safety across escalating doses (up to 7.4 GBq) and promising therapeutic activity. These findings confirm that 161Tb-PSMA RLT is both safe and clinically active, even in patients previously treated with 177Lu-based agents.
Building on this foundation, our study aims to establish a standardized GMP-grade production process for 161Tb-PSMA-I\&T and to evaluate its pharmacokinetics, biodistribution, and radiation dosimetry in a small cohort of Taiwanese patients with mCRPC. These pilot data will generate critical clinical insight and infrastructure, directly informing the design of future Phase Ib/II trials and accelerating national readiness for next-generation PSMA-targeted therapies, especially emphasizing on three specific aims: (1) to establish a GMP-compliant manufacturing process for clinical-grade 161Tb-PSMA-I\&T suitable for clinical application in Taiwan; (2) to characterize 161Tb-PSMA-I\&T focusing on its pharmacokinetics, biodistribution, and radiation dosimetry; (3) to explore preliminary safety data of 161Tb-PSMA-I\&T using potential treatment doses in Asian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalation with 3 dose levels
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: 161Tb-PSMA-I&T120 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles |
| Dose level 2 | Experimental | Drug: 161Tb-PSMA-I&T150 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles |
| Dose level 3 | Experimental | Drug: 161Tb-PSMA-I&T200 mCi of 161Tb-PSMA-I\&T every 6 weeks for 3 cycles |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC)
- Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone analog, with a serum testosterone level <50 ng/dL (castrate range)
- 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)
- Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient
Key exclusion criteria (10 listed)
- 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 prior to first investigational dose
- Prior systemic therapies against prostate cancer within 4 weeks, including androgen receptor pathway inhibitor, chemotherapy, targeted therapy such as PARP inhibitors (PARPi)
- Discordant disease on PET images: FDG-positive disease with minimal PSMA expression
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 |
|---|---|---|
| 161Tb-PSMA-I&T161Tb-PSMA-I\&T for injections, slow intravenous administration, 200 mCi/5 mL/Vial | Drug | Dose level 1, Dose level 2, Dose level 3 |
Primary outcome
Treatment-emergent adverse events
Time frame: From enrollment to the end of post-treatment surveillance, at least 36 weeks
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 across the entire treatment and 18-week post-treatment surveillance period
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 2 Jun 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.
Ching-Chu Lu principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 161Tb-PSMA-I&T in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by National Taiwan University Hospital at 2 sites in Taiwan.
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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Contact Pei-Ju Chuang (+886-2-2322-0322 ext. 237966, pjchuang.ntucc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: From enrollment to the end of post-treatment surveillance, at least 36 weeks). 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 2 Jun 2026.