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Frailty in Older Adults With Prostate Cancer: a Prospective Cohort Study

18 maggio 2026 aggiornato da: University of Limerick

A Prospective Cohort Study to Assess Frailty, Healthcare Needs and Health Related Quality of Life in Patients With a Diagnosis of Prostate Cancer

Prostate cancer is the most common solid tumour cancer amongst men in Ireland, with almost 4,000 new cases diagnosed annually and a median age at diagnosis of 67 years. The incidence of frailty amongst cancer patients is high. Among patients undergoing systemic anti-cancer therapy, frailty increases the risk of treatment related toxicity, hospitalisation, and death and is associated with a poorer quality of life.

This study aims to describe the demographic, clinical and frailty characteristics of men living with prostate cancer in the Mid-West of Ireland. In addition, we will assess the predictive accuracy of three frailty screening tools currently used in Irish clinical practice,G8, CFS and PRISMA 7, for predicting poorer outcomes at baseline, 6 and 12 months.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

Prostate cancer is the most common solid tumour cancer amongst men in Ireland, with almost 4,000 new cases diagnosed annually and a median age at diagnosis of 67 years. Whilst most men present with loco regional disease, 5-10% of men have metastatic disease at diagnosis and others develop metastatic disease later in life.

Frailty, a biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems, and causing vulnerability to adverse outcomes is also associated with increasing age. Both cancer and systemic anticancer therapies can act as significant stressors to the physiological reserve of patients and as a result, the incidence of frailty amongst older cancer patients is high. Among patients undergoing systemic anti-cancer therapy, frailty increases the risk of treatment related toxicity, hospitalisation, and death and is associated with a poorer quality of life.

The prevalence of frailty amongst men with prostate cancer appears to correlate to the extent of disease with the highest prevalence of frailty present in those with advanced metastatic disease. Treatment paradigms for advanced prostate cancer have evolved substantially, with early treatment intensification now considered the standard of care due to demonstrated overall survival benefits. However, treatment intensification, is associated with increased risk of toxicity and therefore poses a concern given the higher risk of competing mortality and morbidity amongst frail patients.

Functional status in oncology practice is predominantly assessed using the The Eastern Cooperative Oncology Group (ECOG) Performance Status Score or Karnofsky performance status which guide treatment decisions and predict treatment toxicity and overall survival .The limitations of these measures in the assessment of a heterogeneous population such as older adults, has been recognised. As such, it is recommended that a frailty assessment is undertaken for older patients and embedded into the decision-making regarding a patient's suitability for systemic anticancer therapy

A variety of frailty identification tools have been utilised in the oncology setting including: Clinical Frailty Score (CFS) , Geriatric 8 screening tool (G8) , Fried Frailty Phenotype and Vulnerable Elders Survey 13 (VES13) , with the G8 and VES being the most frequently used. Lower G8 scores have been associated with poorer oncological outcomes in older cancer patients while VES may demonstrate higher specificity for frailty prediction than G8 (as assessed by GCA). Although recommended and utilised clinically, frailty screening tools have yet to be validated for tailoring final anticancer treatment or frailty intervention plans.

This study aims to describe the demographic, clinical and frailty characteristics of men living with prostate cancer in the Mid-West of Ireland. Participants will be followed longitudinally over 12 months. In addition, we will assess the predictive accuracy of three frailty screening tools currently used in Irish clinical practice,G8, CFS and PRISMA 7, for predicting adverse outcomes at baseline, 6 and 12 months. The findings will provide important real-world insights into frailty, treatment practices, and patient-centred outcomes in prostate cancer, and may help inform future screening strategies and intervention studies

Tipo di studio

Osservativo

Iscrizione (Stimato)

80

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Munster
      • Limerick, Munster, Irlanda, V94 F858
        • Reclutamento
        • University Hospital Limerick
        • Contatto:
          • Niamh Peters Dr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

All adults ≥ 65 years old with prostate attending outpatient clinics at the Mid-Western Cancer Centre between April 2026 and April 2027 (inclusive) will be considered eligible for participation in the study.

Descrizione

Inclusion Criteria:

  • adults aged ≥65 years with a diagnosis of prostate cancer

Exclusion Criteria:

  • Neither the patient nor the carer has sufficient proficiency in English sufficiently to complete consent or baseline assessment
  • Patients will be excluded if they present outside of research nurse (RN) operational hours( 8am and 5pm Monday - Friday).
  • Patients who are acutely unwell and unable to answer the questionnaire will also be excluded.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional status
Lasso di tempo: Baseline, six months and twelve months after index visit

Patient global functioning as measured through the Barthel Index of Activities of Daily Living.

The Barthel Index is a 10-item scale used to assess functional independence. The scoring varies across items:

bowels, bladder, toilet use, feeding, dressing, and stairs are scored from from 0 (dependence or inability) to 2 (independence) grooming and bathing are scored either 0 (dependent or needs help) or 1 (independent) transfer and mobility are scored 0 (dependent), 1 (major help), 2 (minor help), or 3 (independent).

The total score ranges from 0 to 20 and it is obtained by adding up the scores of each item. Lower scores indicated increased disability. In case of rehabilitation, changes of more than two points in the total score reflect a probable genuine change, and change on one item from fully dependent to independent is also likely to be reliable.

Baseline, six months and twelve months after index visit

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient quality of life
Lasso di tempo: Baseline, Six months and twelve months after index visit.

Quality of life assessed through the EuroQoL-5D-5L (EQ-5D-5L). The EQ-5D-5L is a standardised instrument developed by the EuroQoL Group (https://euroqol.org/euroqol/) to measure health-related quality of life.

It includes a descriptive questionnaire assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 5 levels of self-rated severity (1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems). Each dimension is scored separately from 0 to 5 and the patient's "health state" is coded as a 5-digit string.

It also includes a vertical visual analogue scale (VAS) to record the patient's self-rated health on a scale from 0 (worst health) to 100 (best health). The score assigned by the patient represents the self-reported level of health.

Baseline, Six months and twelve months after index visit.
Incidence of healthcare utilisation
Lasso di tempo: six months and 12 months following index visit
Percentages of patients who visit a general practitioner (GP), a public health nurse, outpatient departments, private consultations, home help, or allied health services after the ED index visit
six months and 12 months following index visit
Mortality
Lasso di tempo: six months and 12 months
The rates of patients deceased will be captured at follow-up
six months and 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 aprile 2026

Completamento primario (Stimato)

1 novembre 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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