^
    5d
    Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer (clinicaltrials.gov)
    P2, N=93, Completed, Institut Paoli-Calmettes | Unknown status --> Completed | N=206 --> 93
    Trial completion • Enrollment change
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    apalutamide
    6d
    PROTEUS: A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (clinicaltrials.gov)
    P3, N=2517, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Feb 2026 --> Dec 2026
    Trial primary completion date
    |
    apalutamide
    8d
    SCALP1: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (clinicaltrials.gov)
    P3, N=703, Active, not recruiting, Cassiopea SpA | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    14d
    Behavioral Alterations in Male Zebrafish After Administration of Androgen Receptor Blockers and an Activator. (PubMed, Biology (Basel))
    Enzalutamide (ENZ) and apalutamide (APA) are two second-generation androgen receptor inhibitors (SGARIs) that have been primarily used in the treatment of prostate cancer. In conclusion, functional modulation of androgen receptor signaling leads to significant alterations in male zebrafish behavior, particularly affecting fear responses, aggression, and anxiety-related behaviors. We believe that these findings could contribute to a deeper understanding of the relationship between androgens and behaviors in vertebrates, especially zebrafish.
    Journal
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    AR (Androgen receptor)
    |
    Xtandi (enzalutamide) • apalutamide
    17d
    1% Clascoterone Cream for the Treatment Acne Vulgaris (clinicaltrials.gov)
    P3, N=692, Not yet recruiting, Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
    New P3 trial
    21d
    OBSAPA: A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France (clinicaltrials.gov)
    P=N/A, N=270, Recruiting, Janssen Cilag S.A.S.
    New trial
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    apalutamide
    28d
    Sustained Drug-Drug Interaction Between Cyclosporine and Apalutamide in a Patient With Metastatic Hormone-Sensitive Prostate Cancer: A Case Report and Evaluation of CYP3A4 Induction via Pregnane X Receptor Activation by Apalutamide. (PubMed, Case Rep Oncol Med)
    A 75-year-old man with mHSPC was treated with Apa and leuprorelin. Apa induced CYP3A4 via the PXR pathway, leading to a sustained DDI with CsA. Careful monitoring is necessary when Apa is coadministered with CYP3A4 substrates.
    Journal
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    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    apalutamide • cyclosporine • leuprolide acetate for depot suspension
    30d
    Transcriptomic analysis to uncover the mechanism of radiosensitization of AR-positive triple-negative breast cancers with AR inhibition. (PubMed, NPJ Breast Cancer)
    Mechanistically, while stimulation with the AR-agonist R1881 is sufficient to induce nuclear translocation of AR in AR+ TNBC cells, AR inhibition with enzalutamide, apalutamide, or darolutamide blocked AR nuclear translocation. These findings suggest that AR-mediated radioresistance is at least partially due to downstream MAPK/ERK signaling. Together this work builds on the mechanistic understanding of AR-mediated radioresistance in AR+ TNBC which may expose vulnerabilities in resistance to combination treatment with AR inhibition and RT.
    Journal
    |
    AR (Androgen receptor)
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    AR positive
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    1m
    INT22-09-01: Study to Determine Possible Effects of Apalutamide, Compared to Placebo, on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
    P1, N=80, Not yet recruiting, University of Wisconsin, Madison | Trial completion date: Jul 2027 --> Dec 2028 | Trial primary completion date: Jan 2027 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    EGFR expression
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    apalutamide
    2ms
    Validated LC-MS/MS Method for Quantification and Pharmacokinetic Analysis of Talazoparib and Enzalutamide in Rats. (PubMed, Biomed Chromatogr)
    This study developed and validated an LC-MS/MS method for simultaneous quantification of Talazoparib and Enzalutamide in rat plasma using Apalutamide as the internal standard. In pharmacokinetic studies on male Wistar rats, Talazoparib showed a Cmax of 0.88 ng/mL at 3 h and an AUC0-t of 20 ng·h/mL, while Enzalutamide exhibited a Cmax of 76.18 ng/mL at 1 h and an AUC0-t of 1702 ng·h/mL; both had 24 h half-lives. The validated method enables sensitive, rapid, and reliable bioanalysis for preclinical pharmacokinetic evaluation.
    PK/PD data • Preclinical • Journal • PARP Biomarker
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    HRD (Homologous Recombination Deficiency)
    |
    Talzenna (talazoparib) • Xtandi (enzalutamide) • apalutamide
    2ms
    A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=23, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Completed --> Active, not recruiting | Trial completion date: Oct 2024 --> Dec 2027
    Enrollment closed • Trial completion date
    |
    apalutamide • midazolam hydrochloride
    2ms
    c15-164: AASUR in High Risk Prostate Cancer (clinicaltrials.gov)
    P2, N=64, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Jan 2026 | Trial primary completion date: May 2026 --> Jan 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    abiraterone acetate • apalutamide • leuprolide acetate for depot suspension