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    DRUG:

    Nubeqa (darolutamide)

    i
    Other names: ODM-201, BAY-1841788 , ODM 201, BAY 1841788
    Company:
    Bayer, Orion Corp
    Drug class:
    Androgen receptor inhibitor
    Related drugs:
    1m
    IUNU-PC-123: 177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial (clinicaltrials.gov)
    P4, N=20, Not yet recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    New P4 trial
    |
    Nubeqa (darolutamide) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
    1m
    ASCERTAIN: A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (clinicaltrials.gov)
    P1, N=113, Completed, AstraZeneca | Recruiting --> Completed
    Trial completion
    |
    Nubeqa (darolutamide) • saruparib (AZD5305)
    1m
    Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov)
    P3, N=27, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial primary completion date: Jun 2026 --> Sep 2026
    Trial primary completion date
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Viadur (leuprorelin implant)
    1m
    Quality of Life and Psychological Factors in Patients with Metastatic Prostate Cancer Receiving Androgen Receptor-Targeted Therapies: A Prospective Cross-Sectional Real-World Study. (PubMed, Medicina (Kaunas))
    Materials and This prospective cross-sectional, single-center observational study included 130 patients with metastatic prostate cancer receiving AR-targeted therapies (abiraterone, enzalutamide, or apalutamide/darolutamide). These findings highlight the importance of integrating routine psychosocial assessment and supportive care strategies into clinical practice to optimize patient-centered outcomes. However, given the cross-sectional and exploratory nature of the study, the findings should be interpreted cautiously.
    Observational data • Journal • HEOR • Real-world evidence
    |
    AR (Androgen receptor)
    |
    enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • apalutamide
    1m
    A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described (clinicaltrials.gov)
    P=N/A, N=805, Active, not recruiting, Bayer | Trial primary completion date: Dec 2026 --> Jul 2026
    Trial primary completion date
    |
    Nubeqa (darolutamide)
    1m
    Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment (clinicaltrials.gov)
    P1, N=10, Terminated, Eli Lilly and Company | Completed --> Terminated; The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.
    Trial termination
    |
    Verzenio (abemaciclib) • Nubeqa (darolutamide)
    1m
    A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide (clinicaltrials.gov)
    P=N/A, N=3000, Recruiting, Bayer
    New trial • Adverse events
    |
    enzalutamide • Nubeqa (darolutamide)
    2ms
    Pathological complete response to perioperative treatment with darolutamide plus ADT in locally advanced prostate cancer without PTEN or RB1 loss: a case report. (PubMed, Front Pharmacol)
    The initial intensified systemic regimen is the doublet therapy of Darolutamide (600 mg orally twice daily) and goserelin (10.8 mg administered subcutaneously every 3 months). During 20 months of follow-up, the patient maintained an undetectable PSA, and had no radiographic evidence of disease relapse with well treatment tolerance. This case suggests that darolutamide plus ADT, administered as a tailored perioperative intensified systemic strategy, may induce a rapid and profound PSA response and may be associated with pCR in selected patients with very high-risk LAPC, while further investigation is warranted.
    Journal
    |
    PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1)
    |
    Nubeqa (darolutamide) • goserelin acetate
    2ms
    ARACOG: Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide (clinicaltrials.gov)
    P2, N=111, Completed, Alliance Foundation Trials, LLC. | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> May 2026
    Trial completion • Trial completion date
    |
    enzalutamide • Nubeqa (darolutamide)
    2ms
    The DARO-flare trial: evaluating the impact of darolutamide on prostate-specific membrane antigen (PSMA) flare and its implications for imaging and staging of hormone-sensitive prostate cancer - study protocol. (PubMed, BMJ Open)
    Study findings will be disseminated through peer-reviewed publications and conference presentations. 2025-520482-52-03 (https://euclinicaltrials.eu/ctis-public/view/2025-520482-52-03?lang=en, protocol nr 6.0).
    Clinical protocol • Journal
    |
    AR (Androgen receptor) • FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Nubeqa (darolutamide)
    2ms
    DADOX: A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer (clinicaltrials.gov)
    P=N/A, N=100, Active, not recruiting, Bayer | Trial primary completion date: Jul 2026 --> Mar 2026
    Trial primary completion date • Real-world evidence
    |
    docetaxel • Nubeqa (darolutamide)
    2ms
    PSMA-DaroRT: PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC (clinicaltrials.gov)
    P2, N=254, Not yet recruiting, West China Hospital
    New P2 trial
    |
    Nubeqa (darolutamide)