Xofigo (radium Ra-223 dichloride) / Bayer - LARVOL DELTA

From animals to computational oncology: Digital twins as ethical enablers of next-generation bone metastasis research (AACR 2026) - "We further conducted robust double verification by simulating both the anti-angiogenic effects of cabozantinib and the anti-resorptive effects of zoledronic acid...Computational compression tests revealed increased fragility in trabecular bone following treatment with the bone-targeting agent Radium-223, whereas three-point bending tests showed no fragility in cortical bone post-treatment...Overall, our digital twin approach provides a transformative platform to dissect tumor progression, predict therapy response, and evaluate the consequences on bone mechanics. By enabling these insights in silico, we aim to significantly reduce dependence on animal models, directly supporting and strengthening the 3Rs principle."

Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Impact of Bone-Directed Radiation Therapy on Radium-223 Response in mCRPC: A Retrospective Analysis Correlated with PSMA PET/CT and Bone Scan (PSMA 2026) - No abstract available

Retrospective data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

Phase 3 PEACE-3 Trial (NCT02194842) (Cancer Network) - "Combining enzalutamide (Xtandi) with radium-223 (Xofigo) boosted overall survival (OS) compared with enzalutamide alone among patients with metastatic castration-resistant prostate cancer (HR, 0.75; 95% CI, 0.60-0.95; P = .0078); Previously reported rPFS improvements with the combination were sustained with longer follow-up, as data showed a median rPFS of 19.2 months vs 16.4 months in the experimental and comparator arms, respectively."

P3 data • Prostate Cancer

Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial. (PubMed, Ann Oncol) - "PEACE-3 demonstrates that combining enzalutamide with Ra223 as first-line therapy for mCRPC significantly improves rPFS. Although statistically significant at the OS interim boundary, the study will continue to the final OS analysis."

Journal • Cardiovascular • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Hematological Disorders • Hypertension • Musculoskeletal Diseases • Neutropenia • Oncology • Pain • Prostate Cancer • Solid Tumor

Final overall survival results from the EORTC 1333/PEACE-3 trial: Enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. (ASCO-GU 2026) - P3 | "The final results of EORTC1333/PEACE-3 confirm that adding six cycles of radium-223 to enzalutamide significantly prolongs overall survival in men with bone-dominant mCRPC, supporting the synergistic potential of this combination. Detailed analyses of efficacy, safety, and subgroups will be presented."

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

A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis. (ASCO 2025) - P1/2 | " Patients were randomized 1:1 to olaparib + radium-223 (Arm A) vs. radium-223 (Arm B), stratified by prior docetaxel and BM extent (≤20/>20). In this phase 2, multicenter trial, olaparib + radium-223 demonstrated superior rPFS to radium-223, in both HRR+ and HRR- groups, with manageable side effect profile in CRPC patients with BM. Tissue and serial ctDNA analyses are underway and will be presented."

Biomarker • Clinical • P2 data • Anemia • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Circulating tumor DNA (ctDNA) dynamics in bone-dominant metastatic castration resistant prostate cancer (mCRPC) treated with radium-223 with or without olaparib: Biomarker analyses from the multicenter, randomized, phase 2, investigator-initiated COMRADE trial. (ASCO-GU 2026) - P1/2 | "Early MR (by C2D1) was achieved in 35% of patients and strongly associated with improved rPFS and OS while PSA50 responses by C2D1 were not observed in any patients. The rPFS benefit of adding olaparib to radium-223 appeared more evident in those who achieved a MR. Early on treatment ctDNA dynamics in bone-dominant mCRPC may be a valuable tool for treatment decisions with radium-223 therapy."

Biomarker • Circulating tumor DNA • Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A randomized trial of radium-223 dichloride and cabozantinib in patients with advanced renal cell carcinoma (RCC) with osseous metastases (RADICAL/Alliance A031801). (ASCO 2025) - P2 | "The study was activated in July 2020 and accrual is ongoing throughout the National Clinical Trials Network (NCTN). Continued site participation and enrollment are essential to evaluate this therapeutic strategy."

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

Long-term outcomes with radium-223 in metastatic castration resistant prostate cancer: US patient subset of the 10-year REASSURE global study. (ASCO-GU 2026) - P | "In this descriptive analysis of 10-year real-world data from the US, Ra-223 demonstrated a favorable long-term hematological safety profile in pts with mCRPC. Importantly, incidence of SPMs was low across the observation period and relative to national mCRPC data. OS was consistent with other contemporary studies."

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

Final overall survival results from EORTC 1333/PEACE-3 trial of enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer. (PubMed, Ann Oncol) - "The final analysis of this study confirmed that the combination of enzalutamide with Ra223 significantly improved not only rPFS but also OS as first-line therapy for mCRPC versus enzalutamide alone. Co-administration of a bone-protecting agent is required to reduce skeletal complications."

Journal • Cardiovascular • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hypertension • Oncology • Prostate Cancer • Solid Tumor

Radium 223 without androgen deprivation therapy (ADT) in patients (Pts) with biochemically recurrent prostate cancer (BCR) and PET findings in the bones. (ASCO-GU 2026) - P2 | "Radium-223 in BCR is safe and associated with minimal grade 1/2 toxicities. Decreases in SUVmax seen on most NaF scans suggest Radium-223 targeting of suspicious lesions. Improvements in PSMA imaging have been observed."

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

Real-world effectiveness of systemic therapies after 177Lu]Lu-PSMA-617 (177Lu-PSMA-617) treatment in patients with metastatic castration-resistant prostate cancer (mCRPC): A prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2026) - "Systemic therapies included ARPIs (abiraterone, enzalutamide, darolutamide, apalutamide); chemotherapy (cabazitaxel, docetaxel, carboplatin, cisplatin, etoposide, mitoxantrone); immunotherapy (pembrolizumab, sipuleucel-T); poly (ADP-ribose) polymerase (PARP) inhibitors (niraparib, olaparib, talazoparib, rucaparib); and radium-223. In this real-world analysis, meaningful clinical responses were observed in a subset of patients who received subsequent systemic therapies after 177Lu-PSMA-617."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Keynote Lecture - Radium-223 and combination therapies (TAT-Alpha 2026) - No abstract available

Combination therapy

Long-term safety of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC): 7-year follow-up from the largest global prospective study. (ASCO 2025) - P | "Prior treatments included abiraterone (48% of pts), enzalutamide (39%), docetaxel (39%), and cabazitaxel (9%). This real-world safety analysis of pts with mCRPC is the longest follow-up of a radiopharmaceutical reported to date and supports the well-established favorable safety profile of Ra-223. The incidence of SPMs was low. The rate of fracture was low, especially in the presence of BHAs."

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

A phase I/II trial of combined Radium-223 and Lutetium-177 PSMA-I&T in patients with metastatic castration-resistant prostate cancer (mCRPC): First analysis of the AlphaBet trial (ESMO 2025) - P1/2 | "19 pts (53%) received prior docetaxel. Conclusions The combination of LuPSMA and 223 Ra is safe and well-tolerated, demonstrating antitumour activity in pts with progressive mCRPC and bone metastases. The findings support further evaluation of combined alpha/beta-emitting approaches."

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

Alpha and Beta Emitters in Translational Nuclear Medicine: Clinical Advances, Challenges, and Future Direction. (PubMed, Int J Mol Sci) - "Alpha emitters such as Actinium-225 and Radium-223 are gaining attention for their high linear energy transfer, which allows them to effectively kill cancer cells while minimizing damage to surrounding healthy tissues...However, current research is limited by an incomplete understanding of resistance pathways, insufficient long-term safety and efficacy data, and underdeveloped personalized treatment frameworks. As production technologies improve and safety protocols advance, these emitters will likely play an even more prominent role in both health care and scientific innovation."

Journal • Review • Genito-urinary Cancer • Genitourinary Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor • Thyroid Gland Carcinoma

Radium-223 in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Nov 2027 ➔ Jul 2026 | Trial primary completion date: Nov 2026 ➔ Feb 2026

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

Delayed Survival Benefit of Enzalutamide Plus Radium-223 in Metastatic Castration-Resistant Prostate Cancer: A Reconstructed Individual Patient Data Analysis of the PEACE-3 Trial (AUA 2026) - No abstract available

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

Development and clinical implementation of a simple radium-223 non-completion risk calculator for bone-metastatic castration-resistant prostate cancer (AUA 2026) - No abstract available

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

Real-World Treatment Sequence and Completion Outcomes of Radium-223 With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (AUA 2026) - No abstract available

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Impact of Prior Chemotherapy on Survival and Safety Outcomes of Radium-223 in Metastatic Castration-Resistant Prostate Cancer (AUA 2026) - No abstract available

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

External validation of a prognostic model for overall survival in metastatic castration-resistant prostate cancer patients treated with Radium-223 (AUA 2026) - No abstract available

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

IRST185.04: Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) (clinicaltrialsregister.eu) - P1/2 | N=70 | Active, not recruiting | Sponsor: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. | Recruiting ➔ Active, not recruiting

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

RAPSON: Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Unknown status ➔ Recruiting | Trial completion date: Aug 2022 ➔ Jul 2025 | Trial primary completion date: Aug 2021 ➔ Jul 2025

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

RAPSON: Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Recruiting ➔ Active, not recruiting

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