TheranosticTrials.org

Clinical Trial · NCT07621692

Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T

Overview

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.

Sponsor

National Taiwan University Hospital

Phase

Phase 1

Contacts

Pei-Ju Chuang (CONTACT)

pjchuang.ntucc@gmail.com

+886-2-2322-0322

Ching-Chu Lu (PRINCIPAL_INVESTIGATOR)

Ching-Chu Lu (CONTACT)

kelvinlu@ntuh.gov.tw

+886-2-2312-3456

ClinicalTrials.gov

NCT07621692

Drug / Compound

PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Prior treated with 177Lu-labeled PSMA RLT unless medically unsuitable or declined by the patient
  • Histologically confirmed adenocarcinoma of the prostate with evidence of metastatic castration-resistant prostate cancer (mCRPC)
  • 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
  • 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)

Exclusion

  • 1. History of allergic reaction to PSMA-targeted compounds or radiometals
  • 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
  • Prior radioligand therapy with 223Ra or 177Lu-PSMA within 6 months
  • Prior surgery or radiotherapy within 4 weeks prior to first investigational dose