[161Tb]Tb-PSMA-I&T / Peter MacCallum Cancer Centre - LARVOL DELTA

First-in-human results of terbium-161 [161Tb]Tb-PSMA-I&T dual beta-Auger radioligand therapy in patients with metastatic castration-resistant prostate cancer (VIOLET): a single-centre, single-arm, phase 1/2 study. (PubMed, Lancet Oncol) - P1/2 | "[161Tb]Tb-PSMA-I&T is safe at the maximum administered dose of 7·4 GBq. Further investigation of this promising radionuclide is warranted in larger, randomised clinical trials."

Journal • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Pain • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

First-in-human results of Terbium-161 [161Tb]Tb-PSMA-I&T radioligand treatment in patients with metastatic castration-resistant prostate cancer (VIOLET): a single-centre, single-arm, phase I/II study (SNMMI 2025) - P1/2 | "Purpose/Background: Terbium-161 (161Tb) is a novel radionuclide emitting beta-radiation similar to lutetium-177 (177Lu), and also higher-energy, ultra-short path-length Auger and conversion electrons. Between October 14, 2022 and February 15, 2024, 30 eligible patients were enrolled. Median (IQR) age 69.0 years (66.0-74.8), median baseline PSA 26.9 ng/mL (10.1-70.0), median PSMA SUVmean 8.2 (7.4-10.8) and 20 patients (67%) had received prior docetaxel. There were no dose-limiting toxicities."

Clinical • Metastases • P1/2 data • Anemia • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Hematological Disorders • Oncology • Pain • Prostate Cancer • Solid Tumor • Xerostomia

First-in-human results of terbium-161[161Tb]Tb-PSMA-I&T radioligand treatment in patients with metastatic castration-resistant prostate cancer (VIOLET): A single-centre, single-arm, phase I/II study. (ASCO 2025) - P1/2 | "Median (IQR) age 69.0 years (66.0-74.8), median baseline PSA 26.9 ng/mL (10.1-70.0), PSMA SUVmean 8.2 (7.4-10.8) and 20 patients (67%) had received prior docetaxel. [161Tb]Tb-PSMA-I&T displayed highly encouraging efficacy with few Grade 3 or 4 adverse events. An additional cohort to assess a higher administered radioactivity is planned. Main treatment-related adverse events."

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor

VIOLET: EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Peter MacCallum Cancer Centre, Australia | Active, not recruiting ➔ Recruiting | N=30 ➔ 42 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Enrollment change • Enrollment open • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR

Radiation absorbed dose in patients with metastatic castration-resistant prostate cancer treated with [161 Tb]Tb-PSMA-I&T (PCF 2024) - P1/2 | "Conclusion Beta radiation absorbed dose following [161Tb]Tb-PSMA-I&T are within a safe and expected range for normal organs. Additional radiation from Auger electrons is not accounted for in current models."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [161Tb]Tb-PSMA-I&T. (PubMed, J Nucl Med) - " Enrollment was completed in February 2024. Patients are still receiving [161Tb]Tb-PSMA-I&T."

Journal • Metastases • P1/2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor

Radiation absorbed dose in patients with metastatic castration-resistant prostate cancer treated with [161Tb]Tb-PSMA-I&T (SNMMI 2024) - P1/2 | "Beta radiation absorbed dose following [161Tb]Tb-PSMA-I&T are within a safe and expected range for normal organs. Additional radiation from Auger electrons is not accounted for in current models."

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

VIOLET: EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: Peter MacCallum Cancer Centre, Australia | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • AR