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

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-GU 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

PSMA-Targeted Actinium-225 Therapy in Metastatic Castration-Resistant Prostate Cancer: Comparative Outcomes Between Monotherapy vs. Combination Therapy (AUA 2025) - " Patients in Phase I dose-escalation trials of single agent 225Ac-J591 or 225Ac-J591 combinations (with 177Lu-PSMA-I&T or Pembrolizumab and Androgen Receptor Inhibitor) were included...Prior therapies included chemotherapy in 75 (63%), >1 AR pathway inhibitor in 61 (50%), immunotherapy in 49 (40%), 177Lu-PSMA in 34 (28%), and radium-223 in 20 (16%)... 225Ac-J591 in combination with other agents appears associated with better PFS and OS outcomes compared to single-agent therapy. Overall, improved efficacy does not appear to be at the cost of increased toxicity."

Combination therapy • Metastases • Monotherapy • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Pain • Prostate Cancer • Solid Tumor • Xerostomia

Fracturing the tumor-bone alliance in metastatic prostate cancer with Ra-223 (AACR 2025) - P=N/A | "Radium-223 dichloride (Ra-223) is a calcium-mimetic alpha-emitting radiopharmaceutical homing to bone, approved for the treatment of bone metastases in castration-resistant prostate cancer (CRPC), significantly prolonging overall survival in patients with advanced disease...The increases in bone density and associated transcriptomics alterations pave the way for future investigations into combination therapies that enhance Ra-223's benefits while addressing potential risks. Considering the clinical importance of TFF3, further validation in larger patient cohorts is essential to refine treatment strategies to improve outcomes for patients with CRPC bone metastases."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IL18 • TFF3 • TNFSF11 • TP53

Predicting bone marrow suppression from urinal 8-hydroxy-2'-deoxyguanosine level during the treatment with radium-223 in patients with cancer bone metastasis. (PubMed, Transl Cancer Res) - "In the patient who had bone marrow suppression, a negative correlation between time after first administration of radium-223 and urinal 8-OHdG was observed. These results suggest that a urinal 8-OHdG concentration has a potency of biomarker for bone marrow suppression under the administration of radium-223 in the patient with BM from CRPC."

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

Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=43 | Active, not recruiting | Sponsor: Tufts Medical Center | Trial completion date: Dec 2025 ➔ Dec 2026

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

Real-world utilization patterns and survival in men with metastatic prostate cancer treated with Radium-223 in the United States. (PubMed, Prostate Cancer Prostatic Dis) - "Significant rwOS benefits were identified in men who received Ra-223 as an earlier line of therapy, received Ra-223 in combination with another therapy, and completed ≥5 Ra-223 cycles, underscoring the importance of Ra-223 in the current treatment landscape."

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

Multicenter, international, retrospective study of prognostic factors for Ra223. (PubMed, Sci Rep) - "The number of risk factors (0-1 vs. 2-3) was significantly associated with for poor OS after Ra223 and OS after mCRPC diagnosis in the validation cohort. Our observation suggests that those factors may associate with favorable survival in patients treated with Ra223."

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

Radium-223 alone or in combination (EAU 2025) - No abstract available

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

Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC (clinicaltrials.gov) - P2 | N=45 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed

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

Feasibility of Radium-223 Following Lutetium-177 Prostate-Specific Membrane Antigen- 617 Radioligand (Lu-PSMA) Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC): Initial Clinical Experience (PSMA 2025) - No abstract available

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

EAU 2025: A Case of Progression After Triplet Therapy for mHSPC: Evidence for and Against a Second ARPI (UroToday) - "Of 2,559 patients with mCRPC, 1,980 (77%) received at least one line of life-prolonging therapy (abiraterone, enzalutamide, docetaxel, cabazitaxel, sipuleucel-T, or radium-223)...Dr. Tombal noted that each time a second androgen receptor pathway inhibitor has been used as a 'best valuable comparator', it showed significantly lower radiographic progression free survival and overall survival in most cases...Prolonged responses are sometimes seen, but androgen receptor pathway inhibitor switch should not replace active treatments such as cabazitaxel, PARP inhibitors, LuPSMA, or radium-223...One interpretation of PSMAfore is that slightly delaying the following line of treatment with an androgen receptor pathway inhibitor switch, especially in patients having received abiraterone, is not that detrimental"

Real-world • Castration-Resistant Prostate Cancer

EAU 2025: A Case of Progression After Triplet Therapy for mHSPC: Radium-223 Alone or in Combination (UroToday) - P3 | N=921 | ALSYMPCA (NCT00699751) | Sponsor: Bayer | "With regards to radium-223, Dr. Saad started by discussing the ALSYMPCA trial...In ALSYMPCA, patients receiving radium-223 had significantly improved median overall survival (14.9 months) versus placebo (11.3 months; HR 0.70, 95% CI 0.58–0.83)...Use of radium-223 was also associated with significantly prolonged time to the first symptomatic skeletal event (15.6 versus 9.8 months, HR 0.66, 95% CI 0.52–0.83)....When considering the timing of radium-223 and docetaxel chemotherapy, Dr. Saad notes that it is important to consider a prespecified subgroup analysis from ALSYMPCA that was undertaken to assess the effect of previous docetaxel use on the efficacy and safety of radium-223. In this analysis, there were 526 (57%) of 921 randomly assigned patients that had received previous docetaxel treatment (352 in the radium-223 group and 174 in the placebo group)..."

P3 data • Prostate Cancer

EAU 2025: A Case of Progression After Triplet Therapy for mHSPC: Radium-223 Alone or in Combination (UroToday) - P3 | N=446 | PEACE III (NCT02194842) | "...Dr. Saad discussed PEACE-3, which was an international study in 446 patients with mCRPC and bone metastases randomized 1:1 to combination of enzalutamide and radium-223 versus enzalutamide alone...The trial demonstrated significant improvement in the primary endpoint of radiological progression-free survival: HR 0.69 (95% CI 0.54-0.87; p = 0.0009), with a median radiological progression-free survival of 16.4 (95% CI 13.8-19.2) months in the enzalutamide arm and 19.4 (95% CI 17.1-25.3) months in the enzalutamide and radium-223 arm...Additionally, the interim analysis (at 80% of events) showed that the key secondary endpoint of overall survival also favored the enzalutamide and radium-223 arm (HR 0.69, 95% CI 0.52-0.90, p = 0.0031)....Median overall survival was longer by 17 months from 25.58 months without to 42.87 months with bone protecting agents use (HR 0.56, 95%CI 0.37-0.86)."

P3 data • Castration-Resistant Prostate Cancer

Treatment of metastatic castration-resistant prostate cancer: review of current evidence and synthesis of expert opinions on radioligand therapy. (PubMed, Front Oncol) - "The treatment landscape of mCRPC has evolved rapidly in recent years, introducing various types of systemic therapies, including taxane-based chemotherapy, androgen receptor pathway inhibitors, bone-targeted radionuclides (e.g., radium-223), immune checkpoint inhibitors, poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors, and radioligand therapies (RLTs) [e.g., a prostate-specific membrane antigen (PSMA) ligand labelled with 177Lu]...In addition, it reports on the results of a questionnaire developed and distributed by the Hong Kong Society of Uro-Oncology (HKSUO), with the aim of collecting the perspectives of specialists experienced in the treatment of advanced PCa in Hong Kong with regard to the clinical application of RLT, primarily [177Lu]Lu-PSMA-617/analogue therapy...Subsequently, a panel of 13 local and overseas experts coordinated by the HKSUO discussed the voting results and provided further insights into certain questions. The literature..."

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

(SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting ➔ Recruiting | Trial primary completion date: Aug 2028 ➔ Nov 2028

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

The role of radium-223 in the evolving treatment landscape of metastatic castration-resistant prostate cancer: a narrative review. (PubMed, Crit Rev Oncol Hematol) - "The advent of new androgen receptor pathway inhibitors (ARPIs) such as abiraterone acetate or enzalutamide marks a great advance for treating mCRPC patientd in the pre- and post-docetaxel settings. This is the case of radium-223 which, when administered with enzalutamide, has recently been shown to prolong radiographic progression-free survival vs. enzalutamide alone in the first line in asymptomatic or mildly symptomatic patients with no known visceral metastases. In this narrative review, we summarize the treatment landscape for mCRPC, both from a historical and practical point of view, to understand the new potential of radium-223 as a treatment option in this setting."

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

The Radium-select Study (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: The Netherlands Cancer Institute | Not yet recruiting ➔ Recruiting

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

First Results Of Peace-III: A Randomized, Multicenter, Open-Label Phase Iii Trial Comparing Enzalutamide Versus A Combination Of Radium-223 and Enzalutamide In Asymptomatic Or Mildly Symptomatic Patients With Bone Metastatic Castration-Resistant Prostate Cancer (IPCU 2025) - P3 | "As of March 2018, co-administration of zoledronic acid or denosumab was obligatory. In PEACE-3, 6 cycles of Ra223 in combination with enzalutamide as first-line therapy significantly improved rPFS in patients with mCRPC. This interim analysis demonstrated a statistically significant OS benefit favoring the combination of Ra223 with enzalutamide. A final OS analysis will be performed for further confirmation of these results."

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

NCI-2020-04699: Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=48 | Recruiting | Sponsor: University of Washington | Trial completion date: Aug 2028 ➔ Aug 2029 | Trial primary completion date: Aug 2025 ➔ Aug 2026

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

The Tight Relationship Between the Tumoral Microenvironment and Radium-223. (PubMed, Biomedicines) - "In conclusion, a few studies have taken into consideration the tumoral microenvironment in association with 223Ra. However, its understanding is a priority to better comprehend how to effectively exploit 223Ra and its action mechanism."

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

Adverse Reactions by Radiopharmaceuticals: Retrospective Analysis of the Portuguese National Pharmacovigilance System. (PubMed, Ann Pharmacother) - "Most notified radiopharmaceuticals were, respectively, radium-223 (n = 36, 41.4%), lutetium-177 oxotreotide (n = 12, 13.8%) and iodide-131 (n = 9, 10.3%). Although the number of notifications is limited, these findings provide valuable insights into the types and frequencies of adverse reactions associated with radiopharmaceuticals used in Portugal between 2010 and 2023. The data highlight the importance of continued pharmacovigilance efforts to monitor the safety of these specialized medical products and inform clinical decision-making."

Adverse events • Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder

Radionuclide therapy in 2025: nuclear medicine options in the treatment of metastatic castration-resistant prostate cancer (PubMed, Urologie) - "Significant prolongation of survival through treatment with lutetium-177-PSMA-617 and radium-223-dichloride has led to approval of both substances in late-stage mCRPC. Further study results on the effectiveness of lutetium-PSMA in earlier stages and on the use of the alpha emitter actinium-225 are expected."

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

Mature phase 1 follow up of alpha emitter 225Ac-J591 with 177Lu-PSMA-I&T in advanced prostate cancer. (ASCO-GU 2025) - P1/2 | "Here, we present mature follow up of a phase 1 dose-escalation trial of 225Ac-J591 plus 177Lu-PSMA-I&T (aka PNT2002)...Previous therapies: 11 (61%) with >1 ARPI, 12 (67%) chemo, 5 (28%) sip-T, 3 (17%) radium-223... The combination of PSMA-targeted alpha (via antibody) plus beta (via small molecule) was feasible. High grade AEs were rare and no new safety signals emerged with longer term follow up. Nearly all patients had PSA decline, and 5 had durable disease control off therapy."

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

Re-treatment of metastatic castration-resistant prostate cancer patients with radium-223 therapy in daily practice. (ASCO-GU 2025) - "Radium-223 re-treatment was well tolerated and is therefore deemed safe in selected mCRPC patients. In addition, the high number of administered injections and the high ALP response rates suggest benefit in this cohort of advanced mCRPC patients. Further research should directly compare radium-223 re-treatment and other life-prolonging therapies to determine the position of radium-223 re-treatment within the therapeutic landscape of mCRPC."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • 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 2025) - P2 | "Radium 223 in BCR is safe and associated with rare grade 1/2 toxicities. Decreases in SUV seen on most NaF scans suggest Radium 223 targeting of suspicious lesions. Substantial improvements in PSMA imaging have been observed."

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