^
    14d
    A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, Celgene
    New P1 trial
    |
    itraconazole • rifampicin
    20d
    Apalutamide-induced life-threatening dermatologic toxicity: Clinical histopathological correlations and salvage therapies in four cases: Case report series. (PubMed, Medicine (Baltimore))
    This case report highlights the importance of recognizing and managing apalutamide-associated skin AEs. The development of these AEs appears to be dose-dependent, and early discontinuation or dose reduction of the drug is crucial for controlling the symptoms. A multidisciplinary approach involving oncologists and dermatologists is recommended to optimize the treatment strategy and maintain the patients' quality of life.
    Journal
    |
    CRP (C-reactive protein)
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    apalutamide
    24d
    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 completion date: Jul 2029 --> Oct 2028
    Trial completion date
    |
    apalutamide
    24d
    LIBERTAS: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (clinicaltrials.gov)
    P3, N=420, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2026 --> Oct 2028
    Trial completion date
    |
    apalutamide
    25d
    Delayed regression of atypical meningiomatosis following discontinuation of gender-affirming hormone therapy in a transgender woman: a case report. (PubMed, Br J Neurosurg)
    Cyproterone acetate (CPA) is an antiandrogen that may be used in combination with estradiol in gender reaffirmation therapy...However, its effect appears to be delayed, indicating that cessation alone is suboptimal in cases causing significant mass effect and symptomatology. In such cases, early surgical intervention should be considered.
    Journal
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    PGR (Progesterone receptor)
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    cyproterone acetate
    1m
    Cost-effectiveness analysis of second-generation androgen receptor antagonists for the treatment of metastatic hormone-sensitive prostate cancer. (PubMed, Front Public Health)
    Compared to apalutamide, the ICER for enzalutamide was ¥643,309/QALY, while for darolutamide, the ICER was -¥40,625/QALY. For Chinese mHSPC patients, darolutamide is the most cost-effective treatment at a WTP threshold of ¥287,391/QALY, followed by apalutamide, with enzalutamide being less favorable.
    Journal • HEOR • Cost-effectiveness
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    AR (Androgen receptor)
    |
    Xtandi (enzalutamide) • Nubeqa (darolutamide) • apalutamide
    1m
    Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial (clinicaltrials.gov)
    P2, N=324, Active, not recruiting, NRG Oncology | Trial primary completion date: Mar 2026 --> Mar 2025
    Trial primary completion date
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Decipher Prostate Cancer Test
    |
    apalutamide
    1m
    TMPRSS2 Expression in Lung Tissue of Prostatic Adenocarcinoma Patients: Androgen Deprivation Therapy and Relevance to SARS-CoV-2 Infection. (PubMed, Curr Issues Mol Biol)
    Direct AR antagonists (apalutamide, bicalutamide) produced greater TMPRSS2 suppression than Gonadotropin-Releasing Hormone modulators or androgen biosynthesis inhibitors. Our findings demonstrate that ADT significantly reduces pulmonary TMPRSS2 expression, with direct AR antagonists showing the strongest effect. This suggests a potential mechanistic explanation for differential COVID-19 susceptibility and provides a rationale for investigating AR-targeted therapies as potential protective interventions against SARS-CoV-2 infection severity.
    Journal
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    AR (Androgen receptor) • TMPRSS2 (Transmembrane serine protease 2)
    |
    bicalutamide • apalutamide
    1m
    Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial (clinicaltrials.gov)
    P3, N=1260, Recruiting, Alliance for Clinical Trials in Oncology | Not yet recruiting --> Recruiting | Initiation date: May 2025 --> Nov 2025
    Enrollment open • Trial initiation date
    |
    docetaxel • apalutamide
    2ms
    Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer (clinicaltrials.gov)
    P3, N=239, Completed, Radiation Therapy Oncology Group | Active, not recruiting --> Completed | Trial completion date: Jun 2029 --> Sep 2025
    Trial completion • Trial completion date
    |
    bicalutamide • triptorelin • goserelin acetate • flutamide • leuprolide acetate for depot suspension • orteronel (TAK 700) • Suprefact (buserelin acetate)
    2ms
    Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) (clinicaltrials.gov)
    P1/2, N=127, Completed, Aragon Pharmaceuticals, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    abiraterone acetate • 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, Completed, Aragon Pharmaceuticals, Inc. | Recruiting --> Completed | Trial completion date: Dec 2027 --> Oct 2024
    Trial completion • Trial completion date
    |
    apalutamide • midazolam hydrochloride