An observational study in Frailty at Older Adults and Prostate Cancer, sponsored by University of Limerick. Recruiting at 1 site in Ireland. Open to male participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of Limerick · Observational
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.
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
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.
Exclusion Criteria:
Functional status
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.
Time frame: Baseline, six months and twelve months after index visit
Patient quality of life
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.
Time frame: Baseline, Six months and twelve months after index visit.
Incidence of healthcare utilisation
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
Time frame: six months and 12 months following index visit
Mortality
The rates of patients deceased will be captured at follow-up
Time frame: six months and 12 months
Plan to share: No
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University of Limerick