NCT07605936

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Apr 2026Nov 2027

Study Start

First participant enrolled

April 23, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 26, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Frailty at Older AdultsProstate Cancer

Keywords

frailtyolder adultsprostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, six months and twelve months after index visit

Secondary Outcomes (3)

  • Patient quality of life

    Baseline, Six months and twelve months after index visit.

  • Incidence of healthcare utilisation

    six months and 12 months following index visit

  • Mortality

    six months and 12 months

Eligibility Criteria

Age65 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale or Trans female with prostate cancer
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Limerick

Limerick, Munster, V94 F858, Ireland

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsFrailty

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Niamh Peters

CONTACT

0035361482900niamh.peters@hse.ie

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 26, 2026

Study Start

April 23, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

May 26, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)