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

Radium-223 in Men with Metastatic Castration-resistant Prostate Cancer: A Systematic Literature Review of Real-world Outcomes in Observational Studies. (PubMed, Eur Urol Oncol) - "This is the most comprehensive review of the effectiveness and safety of the use of Ra-223 in a population after the adoption of androgen-receptor pathway inhibitors. The findings highlight the survival benefits of the early use of Ra-223 with completion of five or more cycles, a favorable safety profile, and low rates of fracture when guideline-recommended BHAs are used."

Journal • Observational data • Real-world evidence • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Musculoskeletal Diseases • Oncology • Prostate Cancer • Solid Tumor

Eight-year follow-up of patient outcomes and bone health in radium-223-treated patients: data from the global REASSURE study (SNMMI 2025) - P | "Previous treatments included abiraterone (48% of pts), enzalutamide (39%), docetaxel (39%), and cabazitaxel (9%). Overall, 1472 pts treated from 2014 to 2017 across 191 centres in 20 countries were included in this final analysis (median follow-up 17 months; range 0.3–95.4). The median age was 73 years (range 44–94). Most pts had an Eastern Cooperative Oncology Group performance status of 0 or 1 (80%)."

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

Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH (clinicaltrials.gov) - P4 | N=696 | Active, not recruiting | Sponsor: Bayer | Trial primary completion date: Aug 2025 ➔ Nov 2025

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

Are Bone Scans Still Necessary in the Era of PSMA PET Imaging? (SNMMI 2025) - "None of these patients had received external beam radiation or radionuclide therapy with Pluvicto or Xofigo before these sets of scans. Our findings suggest that bone scans provide minimal additional benefit when used in conjunction with PSMA PET-CT imaging in prostate cancer to identify additional sites of disease and effect treatment change. As PSMA PET-CT has evolved into a standard of care in staging, restaging, and response evaluation in prostate cancer, the routine use of bone scans is unnecessary. Furthermore, from the point of view of pre-treatment planning for Pluvicto, the percentage of PSMA negative disease as identified by bone scan is very small and of questionable significance."

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

Are Bone Scans Still Necessary in the Era of PSMA PET Imaging? (SNMMI 2025) - "None of these patients had received external beam radiation or radionuclide therapy with Pluvicto or Xofigo before these sets of scans. Our findings suggest that bone scans provide minimal additional benefit when used in conjunction with PSMA PET-CT imaging in prostate cancer to identify additional sites of disease and effect treatment change. As PSMA PET-CT has evolved into a standard of care in staging, restaging, and response evaluation in prostate cancer, the routine use of bone scans is unnecessary. Furthermore, from the point of view of pre-treatment planning for Pluvicto, the percentage of PSMA negative disease as identified by bone scan is very small and of questionable significance."

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

A New ERA for radium-223? Optimizing Treatment by Balancing Efficacy and Toxicity Through Combination Therapies. (PubMed, Crit Rev Oncol Hematol) - "Furthermore, the capacity of radium-223 to induce DNA damage in tumor cells provides a strong rationale for potential synergy with PARP inhibitors and immunotherapeutic agents. This review refocuses attention on this radionuclide, providing an updated perspective to re-evaluate the role of radium-223 in the era of radioligands and precision medicine, along with a critical overview of promising future combinations for the treatment of PCa."

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

Dr McKay on Data for Olaparib Plus Radium-223 in CRPC With Bone Metastases (OncLive) - "Rana R. McKay, MD, FASCO, discusses data the combination of olaparib plus radium-223 vs radium-223 monotherapy in castration-resistant prostate cancer."

Video

Radiobiological mechanisms of radium-223 dichloride: a nonclinical study. (PubMed, Int J Radiat Biol) - "The findings provide critical insights into the differential cytotoxic mechanisms of [223Ra]RaCl2 across various cancer cell types and highlight its systemic toxicity in vivo. This improved understanding may facilitate the development of safer and more effective therapeutic radiopharmaceuticals based on [223Ra]RaCl2."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • CASP3 • CASP7 • GSDME

Racial Differences in Radium-223 Treatment Response and Adverse Effects in a Small-Cohort, Pilot, Hypothesis-Generating Observational Study. (PubMed, Ochsner J) - No abstract available

Adverse events • Journal • Observational data

Pharmacological management of prostate cancer-bone metastasis and recent advancements: A comprehensive review. (PubMed, J Oncol Pharm Pract) - "The review discuss about novel agents such as Radium-223 and Lutetium-177...The review also explores combination treatments, where integrating bone-targeted therapies with systemic prostate cancer treatments holding potential for enhanced efficacy. Ongoing clinical trials investigating novel treatment options and advanced drug delivery techniques are highlighted.ConclusionThe advancements signify a promising direction in the treatment of bone metastases in prostate cancer, highlighting the need for continuous innovation to enhance patient care and outcomes."

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

Prognostic value of whole-body diffusion-weighted imaging with background body signal suppression in CRPC patients undergoing Ra-223 therapy: an exploratory analysis. (PubMed, Jpn J Radiol) - "DWIBS is a valuable tool for monitoring treatment response and predicting outcome in patients with CRPC undergoing Ra-223 therapy. Early intervention or treatment modification is recommended for patients with DWIBS-PD."

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

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

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

Drug Utilisation of Radium-223 Under Routine Clinical Practice (DIRECT) in Europe: A Post-Authorisation Safety Study. (PubMed, Oncol Ther) - "Radium-223 use in combination with abiraterone acetate or other systemic mCRPC therapies largely aligned with the 2018 EMA label change. However, after the label change, radium-223 use without ≥ 2 prior lines of systemic mCRPC therapy remained relatively common in the Netherlands and Germany, possibly because radium-223 was previously recommended as first-line treatment for frail patients, and doctors still may consider it for use in these cases. We could not assess patients' eligibility for other systemic mCRPC therapies; therefore, these findings may partly reflect radium-223 on-label use in patients with contraindications for other systemic therapies."

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

Predictions of 225Ac and 223Ra production cross sections from p, α and heavy ion irradiated thorium and uranium targets. (PubMed, Appl Radiat Isot) - "Moreover, when the α-particle energy is below 100 MeV/u, the predicted cross section of 225Ra for the natural uranium target is higher than that for the thorium target, suggesting that α-particle bombardment of the natural uranium target could be a potential new method to improve 225Ac production efficiency. This study provides theoretical reference for subsequent experimental cross section measurement and isotope production."

Journal

DORA: A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer (clinicaltrials.gov) - P3 | N=738 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2026 ➔ Apr 2027 | Trial primary completion date: Jun 2026 ➔ Apr 2027

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

Targeted alpha therapy: a comprehensive analysis of the biological effects from "local-regional-systemic" dimensions. (PubMed, Eur J Nucl Med Mol Imaging) - "In 2013, the first α-particle therapeutic agent, ²²³RaCl₂ (Xofigo®), was approved by the FDA for treating bone metastases in advanced castration-resistant prostate cancer, marking a milestone in clinical translation of alpha-emitters...This review systematically analyzes TAT's tripartite antitumor mechanisms-targeted effects, bystander effects and abscopal effects-thereby constructing a "local-regional-systemic" multidimensional antitumor network. This framework not only clarifies the radiobiological principles of α-emitters but also provides innovative perspectives for advancing TAT applications in tumor precision therapy."

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

COMRADE Trial: Olaparib Plus Radium-223 Improves rPFS Survival in CRPC (Targeted Oncology) - "In an interview, Rana McKay, MD, discusses findings from the COMRADE trial evaluating olaparib plus radium-223 in prostate cancer presented at the 2025 ASCO Annual Meeting."

Video

PSA and alkaline phosphatase changes in the EORTC-1333 PEACE-3 study evaluating the addition of six cycles of radium 223 in metastatic castration-resistant prostate cancer (mCRPC) starting enzalutamide. (ASCO 2025) - P3 | "The addition of six cycles of RA 223 to enzalutamide in the PEACE-3 trial improves PSA response time and rates (≥90%), ALP reduction time (≥30%), and ALP normalization time and rates at 6 and 12 months."

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

Treatment patterns and survival by race among men with metastatic castration-resistant prostate cancer (mCRPC) in the United States: A US electronic medical record database 2020-2023. (ASCO 2025) - "Line of therapy was identified as ARPI, chemotherapy, poly (ADP-ribose) polymerase inhibitors (PARPIs), immunotherapy (pembrolizumab, sipuleucel-T), radiopharmaceuticals (Ra-223, 177Lu-PSMA-RLT), alone or in combination...Overall, ARPI (62%) [abiraterone: 25%; enzalutamide: 24%; apalutamide: 9%; darolutamide 4%] and chemotherapy (22%) [docetaxel 16%; cabazitaxel 6%] were most common first-line treatment (1L Tx) for mCRPC... ARPI and chemotherapy remained the most utilized therapies in mCRPC from 2020 to 2023 in the US. Treatment and survival outcomes did not differ significantly between Whites and AAs in mCRPC. Treatment and survival by race in mCRPC.NE, not evaluable."

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

Treatment patterns, use of healthcare resources, and clinical characteristics of patients with castration-resistant prostate cancer (mCRPC) in Colombia: Preliminary analysis from ProColombia RC study. (ASCO 2025) - "Among the 81 patients (62.3%) who received second-line therapy, 27.1% received ARPI, 59.3% received taxane-based chemotherapy, 9.9% were treated with Radium-223, and 3.7% received PSMA-Lutetium... This study represents the first comprehensive report on the demographic, clinical, treatment patterns, and HRU of mCRPC patients in Colombia. The significant survival differences based on biomarker testing highlight quality of care that patients received. Standardized PC management protocols, developed collaboratively by multidisciplinary teams and multiple institutions in Colombia, could enhance patient outcomes and healthcare efficiency across the country."

Clinical • Castration-Resistant Prostate Cancer • Diabetes • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Hypertension • Metabolic Disorders • Oncology • Palliative care • Prostate Cancer • Solid Tumor • Type 2 Diabetes Mellitus

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

Trial in progress (XALute): Phase 3 study of xaluritamig vs investigator's choice of cabazitaxel or second androgen receptor directed therapy (ARDT) in post-taxane metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P3 | "Exclusion criteria include prior STEAP1-targeted therapy, any anticancer therapy within 4 weeks prior to first dose of study treatment (not including androgen deprivation therapy), prior PSMA-RLT within 2 months of first dose of study treatment unless less than 2 cycles received, and prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment To mitigate risk of cytokine release syndrome, xaluritamig will be administered with step dosing. Cabazitaxel or second ARDT will be administered according to regional prescribing information. Funded by Amgen Inc.; ClinicalTrials.gov number, NCT06691984."

Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • STEAP1

PSMA-targeted actinium-225 therapy in metastatic castration-resistant prostate cancer (mCRPC): Baseline and follow-up PSMA PET parameters associated with outcomes. (ASCO 2025) - P1, P1/2 | " Patients enrolled in phase I dose-escalation trials of 225Ac-J591, either as a single agent (NCT03276572, NCT04506567; n = 87) or in combination (with 177Lu-PSMA-I&T, NCT04886986, n = 18; or pembrolizumab and androgen receptor (AR) inhibitors, NCT04946370 n = 12), were included...Prior therapies included chemotherapy (62%), >1 AR pathway inhibitor (53%), immunotherapy (42%), 177Lu-PSMA (28%), and radium-223 (17%)... Higher baseline PSMA PET metrics, including SUVmean, SUVmax, and TTV are associated with PSA50 response and survival in patients receiving antibody-delivered alpha emitter 225Ac. Higher TTV, yielding more radionuclide delivery to tumor (most commonly bone) is associated with higher grade myelosuppression. However, the tumor antigen sink effect may decrease exposure to other PSMA+ organs leading to less xerostomia and nausea."

Metastases • Anemia • Castration-Resistant Prostate Cancer • Dental Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Xerostomia

A phase l and randomized phase ll trial of radium-223 dichloride, peposertib, and avelumab in advanced metastatic castrate-resistant prostate cancer (mCRPC): Phase l results. (ASCO 2025) - P1/2 | "The combination of Ra-223 and peposertib, with or without avelumab was well tolerated. The triplet combination showed the most promising results at this early evaluation. We continue to accrue in the randomized Phase II portion of the trial."

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

The impact of DNA repair genetic alterations identified by circulating tumor DNA on sensitivity to radium-223 in bone metastatic, castration-resistant prostate cancer. (ASCO 2025) - P, P2 | "This trial is currently open to enrollment at Fred Hutch, University of Wisconsin, and Johns Hopkins, and 22/60 patients have already been enrolled. Clinical trial information: NCT04489719."

Circulating tumor DNA • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor