^
    3d
    Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (clinicaltrials.gov)
    P2, N=2, Active, not recruiting, Rahul Aggarwal | Trial completion date: Feb 2026 --> Feb 2025 | Trial primary completion date: Feb 2025 --> Mar 2024
    Trial completion date • Trial primary completion date
    |
    RB1 (RB Transcriptional Corepressor 1) • SYP (Synaptophysin)
    |
    RB1 deletion • RB1 mutation
    |
    Erleada (apalutamide) • cetrelimab (JNJ-63723283)
    3d
    DynaMO: Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=196, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2025 --> Mar 2026 | Trial primary completion date: May 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    AR (Androgen receptor)
    |
    Yervoy (ipilimumab) • carboplatin • abiraterone acetate • prednisone • cabazitaxel • Erleada (apalutamide)
    12d
    Novel selective agents for the degradation of AR/AR-V7 to treat advanced prostate cancer. (PubMed, Eur J Med Chem)
    The androgen receptor AR antagonists, such as enzalutamide and apalutamide, are efficient therapeutics for the treatment of prostate cancer (PCa). It potently inhibits cell growth with IC50 values of 4.87 ± 0.52 and 2.07 ± 0.34 μM in the LNCaP and 22RV1 cell lines, respectively, and exhibited effective tumor growth inhibition (TGI = 50.9 %) in the 22RV1 xenograft study. These data suggest that 20i has the potential for development as an AR/AR-V7 inhibitor with degradation ability to treat advanced prostate cancer.
    Journal • Metastases
    |
    AR (Androgen receptor)
    |
    AR amplification • AR expression • AR splice variant 7
    |
    Xtandi (enzalutamide capsule) • Erleada (apalutamide)
    14d
    Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov)
    P=N/A, N=42, Active, not recruiting, Medical College of Wisconsin | N=60 --> 42
    Enrollment change
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
    16d
    The protein composition of exosomes released by prostate cancer cells is distinctly regulated by androgen receptor-antagonists and -agonist to stimulate growth of target cells. (PubMed, Cell Commun Signal)
    The data suggest that the cargo of exosomes is controlled by AR-agonist and -antagonists and distinct among the AR-antagonists. Further, exosomes promote growth that might influence the TME. This finding sheds light into the complex interplay between AR signaling and exosome-mediated communication between PCa cells.
    Journal
    |
    AKT1 (V-akt murine thymoma viral oncogene homolog 1) • CTNND1 (Catenin Delta 1) • PAK2 (P21 (RAC1) Activated Kinase 2) • CALM1 (Calmodulin 1)
    |
    Xtandi (enzalutamide capsule)
    25d
    Phase III Study of KX-826 With Adult Male Patients With AGA (clinicaltrials.gov)
    P3, N=740, Active, not recruiting, Suzhou Kintor Pharmaceutical Inc, | Trial primary completion date: Jan 2024 --> May 2024
    Trial primary completion date
    1m
    A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne (clinicaltrials.gov)
    P4, N=20, Active, not recruiting, Sun Pharmaceutical Industries Limited
    New P4 trial
    1m
    A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne (clinicaltrials.gov)
    P4, N=10, Active, not recruiting, Sun Pharmaceutical Industries Limited
    New P4 trial
    1m
    Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate (clinicaltrials.gov)
    P1, N=6, Completed, Aragon Pharmaceuticals, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Feb 2024
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    abiraterone acetate • prednisone • Erleada (apalutamide)
    1m
    YATAGARASU: A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial completion date: May 2024 --> Sep 2025
    Trial completion date • Combination therapy • Metastases
    |
    AR (Androgen receptor)
    |
    AR positive • AR expression
    |
    Erleada (apalutamide) • goserelin acetate
    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=412, Recruiting, Janssen Pharmaceutica N.V., Belgium | Trial completion date: Jan 2030 --> Aug 2029 | Trial primary completion date: Jan 2030 --> Aug 2029
    Trial completion date • Trial primary completion date
    |
    Erleada (apalutamide) • triptorelin • goserelin acetate
    1m
    Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial (clinicaltrials.gov)
    P2; Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Mar 2024 --> Dec 2024 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Trial initiation date
    |
    Decipher Prostate Cancer Test
    |
    Erleada (apalutamide)
    1m
    A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
    P=N/A, N=979, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Aug 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
    1m
    Real-world prostate-specific antigen reduction and survival outcomes of metastatic hormone-sensitive prostate cancer patients treated with apalutamide: An observational, retrospective, and multicentre study. (PubMed, Prostate Int)
    This real-world study on patients with mHSPC treated with apalutamide plus androgen deprivation therapy revealed robust oncological outcomes, aligning with the emerging evidence. The study's hallmark finding highlights the significance of rapid and deep PSA response as a predictor of improved oncological and survival outcomes.
    Retrospective data • Journal • Real-world evidence • Real-world • Metastases
    |
    AR (Androgen receptor)
    |
    Erleada (apalutamide)
    1m
    Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Oncotype DX Genomic Prostate Score® Assay
    |
    abiraterone acetate • prednisone • Erleada (apalutamide)
    2ms
    Combining EPI-7386 w/ Enzalutamide & Androgen Deprivation Therapy for Newly Diagnosed Prostate Cancer (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Pedro Barata, MD, MSc
    New P2 trial • Metastases
    |
    Xtandi (enzalutamide capsule) • masofaniten (EPI-7386)
    2ms
    SFX-01 in hospitalised patients with community-acquired pneumonia during the COVID-19 pandemic: a double-blind, randomised, placebo-controlled trial. (PubMed, ERJ Open Res)
    At days 8 and 15, respectively, 310 and 42 significant differentially expressed genes were identified between groups (false discovery rate adjusted p1). SFX-01 treatment did not improve clinical status or modulate key Nrf2 targets in patients with CAP primarily due to SARS-CoV-2 infection.
    Journal
    |
    IL6 (Interleukin 6) • IL1B (Interleukin 1, beta)
    |
    Sulforadex (sulforafan alfadex)
    2ms
    A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (clinicaltrials.gov)
    P=N/A, N=1000, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
    2ms
    BALANCE: BIOMARKER TRIAL of APALUTAMIDE and RADIATION for RECURRENT PROSTATE CANCER (clinicaltrials.gov)
    P2; Trial primary completion date: Feb 2024 --> Dec 2024
    Trial primary completion date
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Erleada (apalutamide)
    2ms
    NCI-2018-01054: Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PTEN (Phosphatase and tensin homolog)
    |
    AR overexpression • AR expression • AR-V7 expression
    |
    abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
    2ms
    ACIS: An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
    P3, N=982, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2026 --> Dec 2025
    Trial completion date • Combination therapy • Metastases
    |
    abiraterone acetate • Erleada (apalutamide)
    2ms
    SPARTAN: A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P3, N=1207, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2026 --> Dec 2025
    Trial completion date • Metastases
    |
    Erleada (apalutamide)
    2ms
    Markers of bone metabolism and overall survival in men with bone-metastatic hormone sensitive prostate cancer (HSPC): A subset analysis of SWOG S1216, a phase III trial of androgen deprivation with or without orteronel. (PubMed, Prostate Cancer Prostatic Dis)
    In this planned S1216 subset analysis of men with HSPC and bone metastases, elevated serum markers of bone metabolism were significantly associated with worse OS. Bone biomarker levels alone and in combination with patient and tumor characteristics identify unique subsets of men with differential OS outcomes.
    P3 data • Journal • Metastases
    |
    BAP1 (BRCA1 Associated Protein 1)
    |
    orteronel (TAK 700)
    2ms
    Topical Anti-Androgens in Pilonidal Sinus Disease (clinicaltrials.gov)
    P2, N=75, Not yet recruiting, University of Pennsylvania
    New P2 trial
    2ms
    Comparative real-world (RW) evidence on darolutamide (Daro), enzalutamide (Enza), and apalutamide (Apa) for patients (Pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) in the United States: DEAR. (DKK 2024)
    "A lower % of pts discontinued initial ARI tx, progressed to metastasis, or had AEs on daro vs enza/apa. When adjusting for observed BL factors, pts on daro had considerably lower risk of DISC and PROG vs enza/apa. This study confirms daro’s strong efficacy and favorable tolerability profile in a RW setting."
    Real-world evidence • Clinical
    |
    Xtandi (enzalutamide capsule) • Nubeqa (darolutamide) • Erleada (apalutamide)
    2ms
    Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, OHSU Knight Cancer Institute | Trial completion date: Jan 2026 --> Jan 2030 | Trial primary completion date: Jan 2024 --> Jan 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • abiraterone acetate • Erleada (apalutamide) • Yonsa (abiraterone acetate)
    2ms
    PILLAR: Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=26, Active, not recruiting, University of California, San Francisco | Recruiting --> Active, not recruiting | N=60 --> 26 | Trial completion date: Dec 2024 --> Jan 2027 | Trial primary completion date: Dec 2023 --> Jun 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Erleada (apalutamide)
    2ms
    PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. (clinicaltrials.gov)
    P3, N=120, Not yet recruiting, M.D. Anderson Cancer Center
    New P3 trial • HEOR
    |
    Erleada (apalutamide)
    2ms
    Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy (clinicaltrials.gov)
    P1/2, N=18, Not yet recruiting, Stanford University | Trial completion date: Jun 2024 --> Dec 2024 | Initiation date: Jun 2023 --> Mar 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial initiation date • Trial primary completion date
    2ms
    Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Edwin Posadas, MD | Trial completion date: Oct 2026 --> Jan 2027 | Trial primary completion date: Oct 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    Erleada (apalutamide) • carotuximab IV (ENV-105)
    2ms
    Study to Determine Possible Effects of Apalutamide on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P1; Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Jun 2026 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • FGFR3 (Fibroblast growth factor receptor 3) • CD8 (cluster of differentiation 8) • SLAMF6 (SLAM Family Member 6) • ADAR (Adenosine Deaminase RNA Specific) • TCF7 (Transcription Factor 7)
    |
    EGFR expression • AR expression
    |
    Cxbladder
    |
    Erleada (apalutamide)
    2ms
    SATURN: Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    abiraterone acetate • Eligard (leuprolide acetate) • Erleada (apalutamide) • Viadur (leuprorelin implant)
    2ms
    SAVE: Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (clinicaltrials.gov)
    P2, N=202, Recruiting, Cancer Research Antwerp | Trial completion date: Sep 2022 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Erleada (apalutamide) • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
    2ms
    Addressing the risk and management of cardiometabolic complications in prostate cancer patients on androgen deprivation therapy and androgen receptor axis-targeted therapy: consensus statements from the Hong Kong Urological Association and the Hong Kong Society of Uro-Oncology. (PubMed, Front Oncol)
    The panel reached a consensus on 18 statements based on recent evidence and expert insights. These consensus statements serve as a practical recommendation for clinicians in Hong Kong, and possibly the Asia-Pacific region, in the management of cardiometabolic toxicities of ADT or AR axis-targeted therapies in men with PCa.
    Review • Journal
    |
    AR (Androgen receptor)
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
    3ms
    A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) (clinicaltrials.gov)
    P3, N=726, Recruiting, Cassiopea SpA | Not yet recruiting --> Recruiting
    Enrollment open
    3ms
    SCALP1: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (clinicaltrials.gov)
    P3, N=726, Recruiting, Cassiopea SpA | Not yet recruiting --> Recruiting
    Enrollment open
    3ms
    Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study (clinicaltrials.gov)
    P2, N=34, Recruiting, University of Washington | Not yet recruiting --> Recruiting
    Enrollment open
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    Erleada (apalutamide)
    3ms
    ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=9, Terminated, University of Michigan Rogel Cancer Center | Phase classification: P1/2 --> P1
    Phase classification • Combination therapy • Metastases
    |
    Xtandi (enzalutamide capsule) • IONIS-AR-2.5Rx
    3ms
    PANTHER: Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, Daniel George, MD | Trial primary completion date: Feb 2023 --> Feb 2025
    Trial primary completion date • Metastases
    |
    abiraterone acetate • Erleada (apalutamide)
    4ms
    FABP5 Inhibition against PTEN-Mutant Therapy Resistant Prostate Cancer. (PubMed, Cancers (Basel))
    We show that SBFI-103 is well tolerated and can strongly eliminate RCaP tumor cells in vivo. This provides a pre-clinical platform to fight incurable PC and suggests an important role for FABP5 in PTEN-deficient PC.
    Journal
    |
    PTEN (Phosphatase and tensin homolog) • FABP5 (Fatty Acid Binding Protein 5)
    |
    Xtandi (enzalutamide capsule) • Erleada (apalutamide)