Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis, Otsuka - LARVOL DELTA

Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Response assessment of PSMA therapy in metastatic ca prostate: A single institutional experience from Eastern India (ESMO Asia 2025) - "RLT with 177Lu/Lu-PSMA-617had a favourable biochemical and radiologic response with a manageable toxicity profile. The benefit was maximum noted in bone and nodal disease, with comparable fractional reduction in SUV max among them."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

Redefining Prostate Cancer Precision: Radiogenomics, Theragnostics, and AI-Driven Biomarkers. (PubMed, Cancers (Basel)) - "Lutetium-177-PSMA-617 has become the standard radioligand therapy for metastatic castration-resistant prostate cancer, whereas alpha-emitting agents remain under clinical investigation...Integrative models combining imaging, genomic, and liquid biopsy data pave the way toward precision oncology and personalized therapeutic decision-making. Advances in imaging and theragnostics are reshaping prostate cancer management, bridging the gap between molecular biology and clinical practice to enable precision oncology."

Biomarker • Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Therapeutic Advances in Metastatic Prostate Cancer: A Journey from Standard of Care to New Emerging Treatment. (PubMed, Int J Mol Sci) - "We detail the evidence supporting the integration of systemic agents like abiraterone, enzalutamide, and darolutamide into both hormone-sensitive and castration-resistant settings. Furthermore, we highlight the expanding role of radioligand therapies, including radium-223 and Lutetium-177-labeled PSMA-617 (Lu-PSMA-617), as well as the growing impact of PARP inhibitors in genomically selected patients. The emergence of theranostic strategies and next-generation sequencing has paved the way for personalized treatment algorithms, moving toward a truly precision oncology model in PCa. This comprehensive review synthesizes current therapeutic strategies, clinical trial evidence, and future directions aimed at optimizing outcomes and quality of life for patients with advanced prostate cancer."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • PTEN • TP53

ATNM-400, a first-in-class Actinium-225 antibody radioconjugate, demonstrates potent anti-tumor activity and overcomes resistance to enzalutamide and 177Lu-PSMA-617 in prostate cancer models (PCF 2025) - "We hypothesized that ATNM-400 would provide superior efficacy compared to current options and overcome resistance to AR inhibitors (enzalutamide) and PSMA-directed radioligands (177Lu-PSMA-617 or 225Ac-PSMA-617). ATNM-400 showed robust and durable anti-tumor efficacy and a favorable safety profile in preclinical PCa models. These findings support ATNM-400 as a next-generation Actinium-225 therapy - with potential as 1) Monotherapy in CRPC (pre-177Lu-PSMA-617), 2) Combination therapy with AR pathway inhibitors, or 3) Sequential therapy after ARPI or 177Lu-PSMA-617 failure. ATNM-400 holds promise to address critical gaps in mCRPC treatment landscape."

Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

PROQURE-1: EBRT + Lu-PSMA for N1M0 Prostate Cancer (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: The Netherlands Cancer Institute | N=24 ➔ 14 | Recruiting ➔ Completed

Enrollment change • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Shining the PSMA spotlight on peritoneal metastases in prostate cancer. (PubMed, Eur J Nucl Med Mol Imaging) - No abstract available

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Linking Baseline PSMA PET-Derived Parameters to Toxicity, Adverse Events, Pain, and Quality of Life in Patients Treated with [177Lu]Lu-PSMA-617: A Single-Center Retrospective Study. (PubMed, J Nucl Med) - P=N/A | " In this retrospective analysis of patients with mCRPC treated with 177Lu-PSMA-617, baseline quantitative PSMA PET parameters were associated with both treatment-related toxicities and patient-reported outcomes. Validation in a larger, prospective, multicenter cohort is warranted."

Adverse events • HEOR • Journal • Retrospective data • Castration-Resistant Prostate Cancer • Dental Disorders • Genito-urinary Cancer • Hematological Disorders • Oncology • Osteosarcoma • Pain • Prostate Cancer • Solid Tumor • Xerostomia

The Current Practice of Theranostics: Results of a National Survey and Lessons Learned. (PubMed, J Nucl Med Technol) - "Theranostic programs are expanding rapidly, creating a growing need to understand how institutions implement [177Lu]Lu-DOTATATE therapy and [177Lu]Lu-PSMA-617 therapy in clinical practice...The findings emphasize the necessity for consensus guidelines and standardization. This article also explores key lessons learned from real-world implementation, highlighting the evolving nature of theranostic programs as they expand in clinical practice."

Journal

Comparison of imaging-based bone marrow dosimetry methodologies and their dose-effect relationships in [177Lu]Lu-PSMA-617 RLT including a novel method with active marrow localization. (PubMed, EJNMMI Phys) - "The RM AD estimates from the blood-based surrogate were not concordant with the other image-based calculations and did not correlate with changes in blood values. Including patient-specific tumor and marrow distribution information resulted in lower AD for patients with a high bone metastatic burden. These findings have implications for managing hematological toxicities in 177Lu RLT, especially if dosimetry-guided treatment planning is considered."

Journal • Hematological Disorders • Oncology • Osteosarcoma • Solid Tumor

Challenges and Opportunities in Radioligand Therapy. (PubMed, J Nucl Med Technol) - "Although radioiodine provides the historical foundations of theranostics, the prototype RLTs include 68Ga-DOTATATE and 177Lu-DOTATATE, which target somatostatin receptor subtype 2 in neuroendocrine tumors, and 68Ga-PSMA-617 and 177Lu-PSMA-617, which target prostate cancer. RLT, weaponized in cancer management through advances in instrumentation and radiochemistry, is transforming the nuclear oncology landscape. Equitable access to these advanced tools remains a global consideration."

Journal • Review • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • SSTR

Advancements in Targeted Radiopharmaceuticals: Innovations in Diagnosis and Therapy for Enhanced Cancer Management. (PubMed, Chembiochem) - "Clinically approved agents, such as 177Lu-DOTATATE and 177Lu-PSMA-617, are used for neuroendocrine tumors and metastatic castration-resistant prostate cancer, respectively, with significant therapeutic efficacy. The potential avenues include theranostics, predictive modeling for patient selection, and new molecular targeting strategies. This review highlights the transformative potential of RPhs in precision oncology, providing an overview of the current clinical applications and future research trajectories toward improved cancer management."

Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • CXCR4 • GRP-10

A phase 1 study of LY4257496, a novel GRPR-targeted radioligand therapy, in patients with GRPR-positive metastatic ER+ breast cancer and other advanced solid tumors - OMNIRAY (Trial in Progress) (SABCS 2025) - "Dose expansion will enroll pts with ER+, HER2- MBC treated with LY4257496 monotherapy (cohort B1) and in combination with ET (cohort B2), capecitabine (cohort B3), or ET + abemaciclib (cohort B4)...Key exclusions include prior radiopharmaceutical (except 177Lu-PSMA-617 for mCRPC), recent pancreatitis, and untreated central nervous system metastases.Key study objectives: Evaluate safety, antitumor activity, optimal dose, PK, and biodistribution and dosimetry of LY4257496. Table ETa, fulvestrant or imlunestrant; ETb, investigators' choice of aromatase inhibitor, fulvestrant, or imlunestrant1Stoykow C, et al. Theranostics 2016, 6:1641-50"

Clinical • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • GRP-10 • HER-2

PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov) - P1/2 | N=148 | Active, not recruiting | Sponsor: OncoC4, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Jan 2028 ➔ Apr 2026

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Spatial patterns of [68Ga]Ga-PSMA-11 or [18F]PSMA-1007 PET uptake in comparison with [18F]FET PET and contrast-enhanced MRI in brain tumors (SNO 2025) - "PSMA PET shows target expression in brain tumors. PSMA+ volumes are smaller than metabolically active tumor as determined by amino acid PET but similar to CE+ volumes, indicating potential synergism of PSMA-targeted radioligand therapies with strategies to open the blood-brain barrier."

Brain Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Oncology • Prostate Cancer • Solid Tumor • FOLH1

LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH wild type Gliomas Expressing PSMA following standard Treatment (SNO 2025) - "Given potential for strong PSMA expression within glioma neovasculature, we are exploring a PSMA-anchored adjuvant theranostic strategy incorporating PSMA PET imaging and radiopharmaceutical therapy (RPT) for malignant glioma neovessels and microscopic disease.Materials/Methods : This is a phase I, trial-in-progress of adjuvant [177Lu]Lu-PSMA-617 for newly diagnosed, isocitrate dehydrogenase (IDH) wildtype gliomas following upfront standard-of-care temozolomide and external beam radiotherapy (EBRT). The trial is undergoing IRB approval and slated to open in the next month. At the conference, we will share study design details and early patient experience/data."

Clinical • P1 data • Brain Cancer • Genito-urinary Cancer • Glioma • High Grade Glioma • Prostate Cancer • Solid Tumor • FOLH1 • IDH1

LUTACT: Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Thomas Hope | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Comparison of mCRPC [177Lu]Lu-PSMA-617 radioligand therapy with and without concurrent enzalutamide medication in a real-world setting. (PubMed, Eur J Nucl Med Mol Imaging) - P=N/A | "The results suggest that concurrent medication of enzalutamide during PSMA RLT may enhance response and clinical outcomes, underscoring the potential of this specific combination as a promising approach in mCRPC. Future studies, ideally in prospective setting with larger patient cohorts are warranted."

Journal • Real-world evidence • Castration-Resistant Prostate Cancer • Dental Disorders • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Xerostomia

Interventional Radiology in the Era of Radiotheranostics: An Update for Interventional Radiologists! (PubMed, Nuklearmedizin) - "In 2018, the Food and Drug Administration (FDA) approved lutetium-177 (177Lu) DOTATATE (LUTATHERA, Advanced Accelerator Applications [Novartis]) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)...Less than 5 years later, in March 2022, 177Lu vipivotide tetraxetan (PLUVICTO, Advanced Accelerator Applications) received FDA approval for the treatment of prostatespecific membrane antigen-positive castration-resistant metastatic prostate cancer...As more radiotheranostic agents and applications get adopted in clinical practice, interventional radiologists are likely to get exposed to this field in a way or another. In this article, we discuss the fundamentals of radiotheranostic therapy and explore the expanding role interventional radiology (IR) is expected to play as an essential partner in modern oncology practice."

Journal • Review • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • SSTR

Swiss drugmaker Novartis said on Monday it has opened a new 10,000-square-foot factory in Carlsbad, California, to make cancer treatments, as part of its pledge to invest billions into building U.S. sites (KFGO) - "The plant will produce radioligand therapies, which are drugs that deliver cell-killing radioactive particles directly to tumors, the company said. Novartis already markets radioligand drugs Pluvicto for prostate cancer and Lutathera for rare gastrointestinal tumors."

Commercial • Gastrointestinal Cancer • Prostate Cancer

Efficacy, toxicity, and clinical outcomes of 177Lu-PSMA-617 radioligand therapy at 5.5 GBq per cycle in patients with advanced castration-resistant prostate cancer: a prospective, single arm, phase II study. (PubMed, Eur J Nucl Med Mol Imaging) - "177Lu-PSMA-617 at 5.5 GBq per cycle was safe and effective, achieving survival comparable to studies using 7.4 GBq with fewer severe toxicities. Tailored regimens may benefit patients at higher toxicity risk. These data support further studies to optimize dosage, timing, sequencing and combinations of RLT."

Clinical data • Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PSMA Theranostics in Prostate Cancer and Beyond: Current and Future Perspectives. (PubMed, Cancers (Basel)) - "By situating PSMA within this broader biomarker landscape, we outline opportunities for theranostic integration, including predictive models, combination therapies and expansion into non-prostate malignancies. Understanding the biology of PSMA in conjunction with novel biomarkers provides a framework for optimising theranostic applications and advancing personalised cancer care."

Journal • Review • Brain Cancer • Genito-urinary Cancer • Glioblastoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • FOLH1

A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov) - P1/2 | N=123 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Angela Y. Jia, MD PhD | Trial completion date: Sep 2026 ➔ Mar 2027 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor