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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:
    5d
    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
    6d
    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
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    enzalutamide • Nubeqa (darolutamide)
    6d
    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
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    AR (Androgen receptor) • FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Nubeqa (darolutamide)
    6d
    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)
    8d
    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)
    8d
    Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Icahn School of Medicine at Mount Sinai | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial primary completion date
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test • Decipher Prostate Cancer Test
    |
    Keytruda (pembrolizumab) • Eligard (leuprolide acetate) • Nubeqa (darolutamide) • leuprolide acetate for depot suspension
    13d
    ETCTN 10553: Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2027 --> Nov 2026 | Trial primary completion date: Apr 2027 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • Viadur (leuprorelin implant)
    14d
    P300: A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Pathos AI, Inc. | N=252 --> 120
    Enrollment change
    |
    Nubeqa (darolutamide)
    22d
    QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P1 trial
    |
    Nubeqa (darolutamide) • itraconazole • MHB088C • rifampicin
    23d
    PARIS-BIO: Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore (clinicaltrials.gov)
    P2, N=100, Recruiting, Region Stockholm
    New P2 trial
    |
    Nubeqa (darolutamide)
    27d
    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
    28d
    Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Sir Mortimer B. Davis - Jewish General Hospital | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> Nov 2030 | Trial primary completion date: Nov 2027 --> Nov 2030
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Nubeqa (darolutamide)