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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

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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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:

Recurrent vs de novo at the time of initial diagnosis

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

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.

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.

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.

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. 

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.

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NUBEQA® (darolutamide)
About NUBEQA
PP-NUB-GB-2538, August 2025

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

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