^
    20d
    COMRADE: Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis (clinicaltrials.gov)
    P1/2, N=133, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Apr 2025 | Trial primary completion date: Nov 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    HRD (Homologous Recombination Deficiency) • CD4 (CD4 Molecule)
    |
    HRD
    |
    OncoPanel™ Assay
    |
    Lynparza (olaparib) • Xofigo (radium Ra-223 dichloride)
    27d
    Efficacy of Ra-223 in PSMA PET Optimally Selected Patients (clinicaltrials.gov)
    P2, N=54, Recruiting, University of California, San Francisco | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Xofigo (radium Ra-223 dichloride)
    1m
    REASSURE: Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=1474, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    Xofigo (radium Ra-223 dichloride)
    1m
    Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Sep 2024 --> Dec 2024
    Trial completion date • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • Xofigo (radium Ra-223 dichloride)
    2ms
    The Radium-select Study (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, The Netherlands Cancer Institute
    New trial
    |
    Xofigo (radium Ra-223 dichloride)
    2ms
    Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases (clinicaltrials.gov)
    P1, N=8, Terminated, Bayer | Phase classification: P1/2 --> P1
    Phase classification
    |
    Keytruda (pembrolizumab) • Xofigo (radium Ra-223 dichloride)
    3ms
    Biomarkers of bone metabolism in [223Ra] RaCl2 therapy - association with extent of disease and prediction of overall survival. (PubMed, EJNMMI Res)
    BMM are significantly associated with scintigraphic extent of skeletal disease and OS in patients with mCRPC. Particularly, the bone resorption marker CTX-MMP is a promising surrogate marker for prediction of outcome in patients receiving Radium-223 therapy and could potentially improve selection of patients for therapy and assessment of response.
    Journal
    |
    TNFRSF11B (Tumor necrosis factor receptor superfamily member 11B)
    |
    Xofigo (radium Ra-223 dichloride)
    3ms
    (SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
    3ms
    RAPSON: Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=70, Active, not recruiting, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    docetaxel • prednisone • Xofigo (radium Ra-223 dichloride)
    4ms
    Immune effects of α and β radionuclides in metastatic prostate cancer. (PubMed, Nat Rev Urol)
    External beam radiotherapy is used for radical treatment of organ-confined prostate cancer and to treat lesions in metastatic disease whereas molecular radiotherapy with labelled prostate-specific membrane antigen ligands and radium-223 (223Ra) is indicated for metastatic prostate cancer and has demonstrated substantial improvements in symptom control and overall survival compared with standard-of-care treatment...In vitro data demonstrate that single-dose radiotherapy regimes induce a greater immune-suppressive profile than fractionated regimes; less is known about the immune response induced by molecular radiotherapy agents, but evidence suggests that these agents might induce an immune-suppressive systemic immune response, indicated by increased expression of inhibitory checkpoint molecules such as programmed cell death 1 ligand 1 and 2, and that these changes could be associated with clinical response. Different radiotherapy modalities can induce distinct immune profiles, which can either activate or suppress immune-mediated tumour killing and the current preclinical models used for prostate cancer research are not yet optimal for studying the complexity of the radiotherapy-induced immune response.
    Review • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Xofigo (radium Ra-223 dichloride)
    4ms
    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, University of Washington | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial primary completion date • Circulating tumor DNA • Metastases
    |
    Xofigo (radium Ra-223 dichloride)
    5ms
    COMRADE: Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis (clinicaltrials.gov)
    P1/2; Suspended --> Active, not recruiting
    Enrollment closed • Tumor mutational burden
    |
    HRD (Homologous Recombination Deficiency) • CD4 (CD4 Molecule)
    |
    OncoPanel™ Assay
    |
    Lynparza (olaparib) • Xofigo (radium Ra-223 dichloride)
    5ms
    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, Bayer | Trial completion date: May 2025 --> May 2026
    Trial completion date • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Xofigo (radium Ra-223 dichloride)
    5ms
    Radium-223 Treatment Produces Prolonged Suppression of Resident Osteoblasts and Decreased Bone Mineral Density in Trabecular Bone in Osteoblast Reporter Mice. (PubMed, Cancers (Basel))
    Our study shows that Ra-223 affects bone structures that are not involved in bone metastasis. Strategies that improve bone health may reduce fracture risk in patients receiving Ra-223.
    Preclinical • Journal
    |
    BMP4 (Bone Morphogenetic Protein 4)
    |
    Xofigo (radium Ra-223 dichloride)
    5ms
    Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jun 2024 --> Sep 2024
    Trial completion date • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • Xofigo (radium Ra-223 dichloride)
    5ms
    RAPIT: Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone (clinicaltrials.gov)
    P=N/A, N=194, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion
    |
    Xofigo (radium Ra-223 dichloride)
    6ms
    Aggressive variant prostate cancer with multiple subcutaneous metastases: a case report. (PubMed, Int Cancer Conf J)
    A 71-year-old man with bone metastasis of hormone-sensitive prostate cancer was treated with androgen deprivation therapy and apalutamide. Radium-223 and radiation therapy were administered after it become castration resistant...In this case, if the diagnosis of aggressive variant prostate cancer had been made at an earlier time by biopsy specimens, there might have been a possibility to improve the prognosis by the earlier introduction of the platinum-based regimen. The online version contains supplementary material available at 10.1007/s13691-024-00673-7.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    Erleada (apalutamide) • Xofigo (radium Ra-223 dichloride)
    6ms
    Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones (clinicaltrials.gov)
    P2, N=70, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    paclitaxel • Xofigo (radium Ra-223 dichloride)
    6ms
    A Study of Stereotactic Body Radiation Therapy and Radium (Ra-223) Dichloride in Prostate Cancer That Has Spread to the Bones (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=136 --> 12
    Enrollment closed • Enrollment change
    |
    Xofigo (radium Ra-223 dichloride)
    6ms
    (SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: May 2029 --> Aug 2029 | Initiation date: May 2024 --> Aug 2024 | Trial primary completion date: May 2028 --> Aug 2028
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
    6ms
    Rad2Nivo: Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=36, Recruiting, University of Utah | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden • Metastases
    |
    Opdivo (nivolumab) • Xofigo (radium Ra-223 dichloride)
    7ms
    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, Bayer | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Xtandi (enzalutamide) • abiraterone acetate • Xofigo (radium Ra-223 dichloride)
    7ms
    Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones (clinicaltrials.gov)
    P2, N=70, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    paclitaxel • Xofigo (radium Ra-223 dichloride)
    7ms
    Circulating Biomarkers Predictive of Treatment Response in Patients with Hormone-sensitive or Castration-resistant Metastatic Prostate Cancer: A Systematic Review. (PubMed, Eur Urol Oncol)
    BRCA1/2, ATM, and AR alterations detected in liquid biopsies may help clinicians in management of patients with mPCa. The other circulating biomarkers did not reach the LOE required for routine clinical use and should be validated in prospective independent studies.
    Review • Journal • BRCA Biomarker • PARP Biomarker • IO biomarker • Metastases
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase)
    |
    docetaxel • abiraterone acetate • cabazitaxel • Xofigo (radium Ra-223 dichloride)
    7ms
    Does enzalutamide related PSMA upregulation affect outcomes of lutetium-177 PSMA radioligand therapy? (PubMed, Urologia)
    The median age, Gleason score, and prior chemo/hormonal therapies were similar for EZ+ and EZ-, except for radium-223. Enzalutamide treatment prior to Lu-PSMA does not improve patient outcomes when applied remotely. Larger studies evaluating the combination therapies and the timing of enzalutamide are needed to assess its correlation with Lu-PSMA outcomes.
    Journal
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Xtandi (enzalutamide) • Xofigo (radium Ra-223 dichloride)
    8ms
    Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy (clinicaltrials.gov)
    P1/2, N=90, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open • Metastases
    |
    Bavencio (avelumab) • peposertib (M3814) • Xofigo (radium Ra-223 dichloride)
    8ms
    (SEEtoTREAT): SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization (clinicaltrials.gov)
    P=N/A, N=80, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New trial
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • Xofigo (radium Ra-223 dichloride)
    8ms
    REASSURE: Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=1474, Active, not recruiting, Bayer | Trial completion date: Feb 2025 --> Oct 2024
    Trial completion date • Metastases
    |
    Xofigo (radium Ra-223 dichloride)
    8ms
    Final results of a phase I/II dose-escalation study of fractionated dose 177 Lu-PSMA-617 for progressive metastatic castration resistant prostate cancer (mCRPC). (ASCO 2024)
    29 (58%) with prior >2 ARPI, 29 (58%) with >1 chemo, 14 (28%) with Ra-223, 2 (4%) with 177 Lu-J591... A single-cycle of fractionated-dose 177Lu-PSMA-617 is safe. Despite no pre-selection for PSMA expression, most had PSA decline with favorable PFS and OS compared to historical controls and similar to PSMA-selected targeted radionuclide studies administering multiple cycles in a less dose-intense approach.
    P1/2 data • Clinical • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    CELLSEARCH®
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Xofigo (radium Ra-223 dichloride) • 177Lu-rosopatamab tetraxetan (TLX591)
    8ms
    Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov)
    P=N/A, N=1, Completed, Pfizer | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world • Metastases
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • Xofigo (radium Ra-223 dichloride) • leuprolide acetate for depot suspension
    9ms
    Phase III Radium 223 mCRPC-PEACE III (clinicaltrials.gov)
    P3, N=446, Active, not recruiting, European Organisation for Research and Treatment of Cancer - EORTC | Trial completion date: Dec 2025 --> Dec 2028
    Trial completion date • Metastases
    |
    Xtandi (enzalutamide) • Xofigo (radium Ra-223 dichloride)
    9ms
    Randomized Phase II Study Evaluating the Addition of Pembrolizumab to Radium-223 in Metastatic Castration-resistant Prostate Cancer. (PubMed, Cancer Immunol Res)
    Clinical responders possessed lower circulating frequencies of Ki67+ T and myeloid cells at baseline and higher circulating frequencies of TIM-3+ T and myeloid cells by week 9. Although R223+P did not induce T-cell infiltration into the tumor microenvironment, exhaustion of induced peripheral T-cell immune responses may dampen the combination's clinical activity.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule)
    |
    CTLA4 expression
    |
    Keytruda (pembrolizumab) • Xofigo (radium Ra-223 dichloride)
    9ms
    Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=43, Active, not recruiting, Tufts Medical Center | Recruiting --> Active, not recruiting | N=25 --> 43 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Xofigo (radium Ra-223 dichloride)
    9ms
    Lymphocyte Function at Baseline Could Be a New Predictor of Tumor Burden following Six Cycles of Radium-223 Therapy in Patients with Metastasized, Castration-Resistant Prostate Cancer. (PubMed, Cancers (Basel))
    As determined by receiver operating characteristic (ROC) curve analysis, tetanus-specific IL-10 spots at baseline had the highest predictive value (p = 0.005) for tumor burden at month 6, with an area under the curve (AUC) of 0.90 (sensitivity 100%, specificity 78%). In conclusion, we observed an additive effect of treatment with 223Ra on immune function and found that IL-10 secretion at baseline predicted tumor burden at month 6 after treatment.
    Journal • Metastases
    |
    IFNG (Interferon, gamma) • IL10 (Interleukin 10)
    |
    Xofigo (radium Ra-223 dichloride)
    10ms
    ERA 223: Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms (clinicaltrials.gov)
    P3, N=806, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion
    |
    abiraterone acetate • prednisone • Xofigo (radium Ra-223 dichloride)
    10ms
    Radium-223 Dichloride Long-term Follow-up Program (clinicaltrials.gov)
    P4, N=255, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion
    |
    Xofigo (radium Ra-223 dichloride)
    10ms
    REASSURE: Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=1474, Active, not recruiting, Bayer | Trial primary completion date: Nov 2024 --> Aug 2024
    Trial primary completion date • Metastases
    |
    Xofigo (radium Ra-223 dichloride)
    10ms
    Circulating and Imaging Biomarkers of Radium-223 Response in Metastatic Castration-Resistant Prostate Cancer. (PubMed, JCO Precis Oncol)
    Quantitative bone scan assessment with aBSI and CTC analyses are prognostic markers in patients treated with radium-223. AR-V7 expression in CTCs is a particularly promising prognostic biomarker and warrants validation in larger cohorts.
    Journal • Metastases
    |
    AR (Androgen receptor)
    |
    AR splice variant 7 • AR-V7 expression • AR splice variant 7 expression
    |
    Xofigo (radium Ra-223 dichloride)
    10ms
    Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy (clinicaltrials.gov)
    P1/2, N=90, Suspended, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Bavencio (avelumab) • peposertib (M3814) • Xofigo (radium Ra-223 dichloride)
    10ms
    RROPE: Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone (clinicaltrials.gov)
    P2, N=20, Completed, University of Utah | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Aug 2023
    Trial completion • Trial completion date • Metastases
    |
    Xofigo (radium Ra-223 dichloride)
    11ms
    Efficacy of Ra-223 in PSMA PET Optimally Selected Patients (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, University of California, San Francisco | Initiation date: Dec 2023 --> Apr 2024
    Trial initiation date
    |
    Xofigo (radium Ra-223 dichloride)
    11ms
    TRANCE: Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With M+CRPC (clinicaltrials.gov)
    P4, N=24, Active, not recruiting, University Health Network, Toronto | Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Jul 2024 | Trial primary completion date: Dec 2022 --> Sep 2023
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    abiraterone acetate • Xofigo (radium Ra-223 dichloride)