^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    apalutamide

    i
    Other names: ARN 509, JNJ56021927, JNJ-927, JNJ-56021927, ARN-509, ARN509, JNJ 56021927, JNJ927, JNJ 927
    Company:
    Generic mfg.
    Drug class:
    Androgen receptor antagonist
    Related drugs:
    2d
    Real-world comparison of androgen receptor pathway ınhibitors versus docetaxel as first-line treatment in metastatic hormone-sensitive prostate cancer. (PubMed, Curr Med Res Opin)
    We retrospectively analyzed 148 patients with mHSPC treated with either ARPI (abiraterone, enzalutamide, or apalutamide) plus androgen deprivation therapy (ADT) (n = 98) or docetaxel plus ADT (n = 50). In this real-world cohort, ARPI-based therapy was associated with an improvement in rPFS compared with docetaxel, while OS outcomes remained comparable. In the absence of direct randomized comparisons, these findings may provide supportive real-world evidence for the clinical relevance of ARPI-based therapy as a first-line treatment option for patients with mHSPC.
    Journal • Real-world evidence
    |
    AR (Androgen receptor)
    |
    docetaxel • enzalutamide • abiraterone acetate • apalutamide
    13d
    AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (clinicaltrials.gov)
    P3, N=670, Recruiting, AstraZeneca
    New P3 trial
    |
    FOLH1 positive
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • cabazitaxel • apalutamide • Xofigo (radium Ra-223 dichloride) • AiRuiEn (rezvilutamide) • FPI-2265 • prednisolone
    1m
    PRIMORDIUM: A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (clinicaltrials.gov)
    P3, N=692, Active, not recruiting, Janssen Pharmaceutica N.V., Belgium | Trial completion date: Aug 2029 --> Sep 2031
    Trial completion date
    |
    apalutamide • triptorelin • goserelin acetate
    1m
    A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=355, Recruiting, Janssen Research & Development, LLC | N=250 --> 355
    Enrollment change
    |
    apalutamide • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • JNJ-6143 • pasritamig (JNJ-8343)
    1m
    Genetic Predictors of Progression and Skin Rash in Japanese mCSPC Patients Treated With Apalutamide: CUARTET Study. (PubMed, Cancer Sci)
    This study demonstrated that baseline ctDNA predicts prognosis of Japanese patients with mCSPC receiving apalutamide with ADT and identified potential genetic predictors for treatment-related skin rash. Trial Registration: ClinicalTrials.gov identifier: jRCTs071200040.
    Journal
    |
    AR (Androgen receptor)
    |
    apalutamide
    1m
    Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=102, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial primary completion date: Feb 2027 --> Mar 2026
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Oncotype DX Genomic Prostate Score® Assay
    |
    abiraterone acetate • prednisone • apalutamide
    2ms
    Single center, single-arm, Retrospective study on neoadjuvant Tx of HR LPC with apalutamide (ChiCTR2600121368)
    P=N/A, N=40, THE FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY; THE FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY
    New trial
    |
    apalutamide
    2ms
    To evaluate the safety and efficacy of Apololitowereili Monoclonal Antibody combined with FLOT regimen in patients with locally advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. (ChiCTR2600120362)
    P2, N=29, Fuzhou University Affiliated Provincial Hospital; Fuzhou University Affiliated Provincial Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • HER-2 negative
    |
    apalutamide
    2ms
    Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial (clinicaltrials.gov)
    P2, N=532, Recruiting, Mayo Clinic | Trial completion date: May 2029 --> Feb 2031 | Trial primary completion date: May 2029 --> Feb 2031
    Trial completion date • Trial primary completion date
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • apalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
    2ms
    Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC (clinicaltrials.gov)
    P1, N=16, Completed, Weill Medical College of Cornell University | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Oct 2025
    Trial completion • Trial completion date
    |
    CELLSEARCH®
    |
    docetaxel • abiraterone acetate • prednisone • apalutamide
    2ms
    Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study (clinicaltrials.gov)
    P2, N=8, Active, not recruiting, University of Washington | Trial completion date: Apr 2026 --> Apr 2027
    Trial completion date
    |
    apalutamide • Simponi (golimumab)
    2ms
    VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov)
    P2/3, N=464, Recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2026 --> Sep 2026
    Trial primary completion date
    |
    docetaxel • enzalutamide • abiraterone acetate • prednisone • bicalutamide • apalutamide • triptorelin • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension