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The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05941104
Enrollment
100
Registered
2023-07-12
Start date
2023-07-15
Completion date
2025-12-31
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Biological Indicators, Frailty, Prostatic Neoplasms, Quality of Life, Survival

Brief summary

The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy. The main questions it aims to answer are: 1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically. 2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy. Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.

Interventions

OTHERfrailty

Frailty is a group of common clinical syndromes in the elderly, characterized by systematic, dynamic and reversible, the core of which is the decline of physiological reserves and the destruction of self-balance.

Sponsors

Anhui Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
60 Years to No maximum

Inclusion criteria

1. Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology); 2. Radical prostatectomy is planned; 3. Voluntarily sign the informed consent form.

Exclusion criteria

1. Diagnosed with other malignant tumors at the same time; 2. Patients with acute infection.

Design outcomes

Primary

MeasureTime frameDescription
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.

Secondary

MeasureTime frame
Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.

Other

MeasureTime frame
Number of Participants Surviving up to 2 yearsFrom date of hospitalization until the date of death from any cause, assessed up to 2 years.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026