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    mHSPC: Metastatic Hormone-Sensitive Prostate Cancer

    mHSPC Definition  |  Recurrent vs de novo  |  mHSPC Prognosis  |  mHSPC vs CRPC  |  mHSPC Treatment  |  Key Factors Influencing mHSPC management

    What is metastatic hormone-sensitive prostate cancer (mHSPC)?

    Prostate cancer (PC) is the

    most frequently diagnosed cancer in men
    , with one in eight men diagnosed with it during their lifetime, and the
    second most common cause of cancer-related death 
    in men in the UK. A systematic review of autopsy studies reported an increasing prevalence of PC from
    5% at age < 30 years to 59% at age > 79 years
    .

    Up to

    one-third
    of PC patients will develop
    metastases
    . 
    Metastatic hormone-sensitive prostate cancer (mHSPC)
     represents an advanced stage that is still responsive to hormonal therapy. Each year, approximately 55,000 new cases of  prostate cancer are diagnosed in the UK, with around
    13%
     having mHSPC.

    Recurrent vs de novo mHSPC

    Men diagnosed with mHSPC represent a heterogenous group of patients. 

    • The majority present with
      recurrent or metachronous metastatic disease
      , which is an initially localised tumour that undergoes metastasis after local treatment.
    • In contrast, only approximately
      5% 
      present with
      de novo or synchronous metastatic disease
      , where the metastases has already occurred during initial diagnosis. The latter is associated with
      poorer prognosis
      .
    Recurrent vs de novo mHSPC
    Recurrent vs de novo mHSPC

      The trajectory of mHSPC varies greatly depending on two key prognostic factors: (1) whether metastases are present at initial diagnosis (de novo) or develop after earlier treatment (recurrent), and (2) disease volume.

      • Recurrent
         mHSPC patients have a
        better prognosis 
        than those with de novo disease.
      • Disease volume 
        refers to metastasis extent and location, defined by CHAARTED: “high volume” (HV) disease represents the presence of visceral metastases and/or ≥4 bone lesions with ≥1 outside the axial skeleton. Patients not meeting these characteristics have “
        low volume
        ” (LV) disease, which is associated with a
        more favourable prognosis
        .
      • Overall, mHSPC has a significantly lower
        5-year overall survival (OS) rate of 30%
        , compared to 98.2% in those without metastases
        .

      While mHSPC is a metastatic prostate cancer that remains responsive to androgens, castration-resistant prostate cancer (

      CRPC
      ), or previously known as hormone-refractory prostate cancer, is a progression of PC despite achieving
      castrate levels of testosterone 
      (typically <1.7 nmol/L or <50 ng/dL) through androgen deprivation therapy (ADT).

      Learn more on CRPC or nmCRPC

    Treatment of metastatic hormone-sensitive prostate cancer (mHSPC)

    • Primary
      ADT
       has been the first-line standard-of-care treatment of mHSPC for over 50 years. ADT is typically carried out through either chemical castration (the use of LHRH agonist or antagonist), or surgery castration (orchiectomy).
    • Despite having initial response to ADT monotherapy, most patients still
      progress to mCRPC within 1 year
      . This progression is associated with
      poor prognosis and reduced health-related quality of life (QoL)
      .
    • Clinical trials have demonstrated improved OS and delayed
      progression to mCRPC
       when ADT is combined with a
      second-generation androgen receptor inhibitor (ARI),
       such as
      NUBEQA (darolutamide
      ), either in a
      doublet
       therapy or a
      triplet
       therapy with the addition of docetaxel chemotherapy.
    • Second-generation ARIs work by inhibiting androgen receptor function by blocking the ligand-binding domain and they also prevent nuclear translocation and interaction of the dimerized androgen receptor with DNA.
    • For the treatment of mHSPC, NUBEQA is the only second-generation ARI approved for mHSPC with or without docetaxel.
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    Learn more about NUBEQA (darolutamide) Guidelines
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    Explore NUBEQA (darolutamide) Mechanism of Action

    Key Factors Influencing mHSPC management

    The primary treatment goal for mHSPC patients is to

    increase the overall survival, delay disease progression, and maintain QoL
    . Treatment selection is dependent on multiple factors as shown below:

    Arrow in circle Icon

    Recurrent vs de novo at the time of initial diagnosis

    Types of mHSPC have different prognosis and may benefit from different treatments.

    Up and Down Icon

    Disease Volume

    Disease volume is a key predictive factor in the selection criteria for treatment. Many trials stratified their analyses based on the CHAARTED criteria of low- and high-volume disease.

    Orange Warning Sign Icon

    Toxicity & tolerability

    The effects of the drugs on the QoL must be taken into consideration. With a median OS of approximately 4 years from the time of diagnosis of mHSPC, it is important to balance efficacy of treatment with any treatment-related adverse events, particularly long-lasting effects which may compromise the patient’s QoL.

    Individual with plus symbol icon

    Estimating life expectancy & health status

    Evaluation of life expectancy and health status is important in clinical decision-making for mHSPC treatment. Active treatment mostly benefits patients with intermediate- or high-risk PC and longest expected survival.

    Heart symbol in hands

    Comorbidities

    Comorbidity is a major predictor of non-cancer-specific  death in localised PC treated with RP and is more important than age. Most men with a high co-morbidity score die from competing causes, irrespective of age or tumour aggressiveness. 

    DNA Icon

    Genetic & biochemical biomarkers

    A variety of markers have been studied for their ability to prognosticate patients and even predict treatment response.

    For most patients, metastatic prostate cancer is an

    incurable disease
    . The aim is to transform mHSPC into a
    manageable chronic illness 
    so that the patient dies with the cancer, rather than of it. All treatment decisions and goals must be
    individualised
     in discussion with the patient about the potential benefits and risks of the different treatments.

    NUBEQA
    NUBEQA® (darolutamide)
    About NUBEQA
    PP-NUB-GB-2950, March 2026

    For full information on NUBEQA (darolutamide) in the treatment of mHSPC, please refer to the
    Summary of Product Characteristics (SPC)

    Abbreviations

    ADT, androgen deprivation therapy; ARI, androgen receptor inhibitor; CHAARTED, Chemo-hormonal Therapy versus Androgen Ablation  Randomised Trial for Extensive Disease in Prostate Cancer; CRPC, castration-resistant prostate cancer; ECOG, Eastern Cooperative Oncology Group; HV, high volume; LHRH, luteinizing hormone-releasing hormone; LV, low volume; mHSPC; metastatic hormone-sensitive prostate cancer; nmCRPC, non-metastatic castration-resistant prostate cancer; NICE, National Institute for Health and Care Excellence; OS, overall survival; PC, prostate cancer; PS, prostate-specific; QoL, quality of life; RP, radical prostatectomy; SPC, Summary of Product Characteristics.

     

    PP-NUB-GB-2551 | August 2025

      • 1
        Prostate Cancer UK. About prostate cancer. Available at: https://prostatecanceruk.org/prostate-information-and-support/risk-and-symptoms/about-prostate-cancer/ [Accessed August 2025].
      • 2
        Cancer Research UK. Prostate Cancer Statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer [accessed August 2025].
      • 3
        European Association of Urology. Guidelines on Prostate Cancer. 2025. Available at: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-EANM-ESTRO-ESUR-ISUP-SIOG-Guidelines-on-Prostate-Cancer-2025_2025-03-24-120144_rinw.pdf [Accessed August 2025].
      • 4
        Ng K, et al. Oncol. Ther. 2020;8, 209–230.
      • 5
        Hunnisett, A & Victor, D. British Journal of Nursing. 2022; 31(10): S4-S13.
      • 6
        Serritella AV, et al. Curr. Treat. Options Oncol. 2024;25, 293–312.
      • 7
        Saad F, et al. J. Clin. Oncol. 2024;42, 4271–4281.
      • 8
        Saad F, et al. Prostate Cancer and Prostatic Diseases. 2021; 24(2), 323–334.
      • 9
        NUBEQA (darolutamide) Summary of Product Characteristics.
      • 10
        XTANDI® (enzalutamide) SmPC. Available at: https://www.medicines.org.uk/emc/product/10318/smpc (last accessed August 2025).
      • 11
        ERLEADA® (apalutamide) SmPC. Available at: https://www.medicines.org.uk/emc/product/9832/smpc (last accessed August 2025).