Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04863352 |
| Other study ID # |
150410 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2021 |
| Est. completion date |
November 19, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Sykehuset Innlandet HF |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this study, addressing prostate cancer survivors, i.e. men who received potentially
curative (radical) treatment two to six years ago, we will investigate if older age at time
of treatment is a detrimental factor with respect to long-term quality of life (Qol), health,
and function. We will also compare QoL, health and function between the prostate cancer
survivors and matched population based cohorts, and thereby provide realistic information on
the long-term impact of radical prostate cancer treatment
Description:
Prostate cancer is the most common male cancer in Norway, with almost 5000 new cases yearly.
More than12 % of men contract prostate cancer before the age of 75. As 5-year survival is
high (>95%), a significant proportion of the older male population are prostate cancer
survivors. The quality of life (QoL) and daily function of these older males need elucidation
to provide adequate health care services and information to this large patient group.
The present project includes two studies(Study I and IIA). Study I is investigating the QoL,
health status, and local adverse treatment effects in all men 2-6 years after radical
treatment for prostate cancer. Local adverse treatment effects are defined as problems
related to organs and structures adjacent to the prostate gland (e.g. bowel and urinary
problems, and sexual dysfunction). Study IIA will focus on older prostate cancer survivors,
defined as men who were 70 years or older by the time of treatment. To complete the overall
project, we also plan a later study, Study IIB, that will investigate in more detail the
physical functioning and performance of the older survivors.
Design Study I: A cross-sectional survey targeting all patients from the catchment area of
Innlandet Hospital Trust (SI-HF) who received radical treatment for localized/locally
advanced prostate cancer at SI-HF from 2014 to 2018 Study II A: A supplementary
cross-sectional survey targeting older participants from Study I who were >70 years at time
of treatment Control groups: For comparison with a general population, we will use existing
data from male participants in the fourth wave of the Trøndelag Health Study (HUNT4)
including the HUNT4 70+ survey. Control groups will be drawn, matched on age and education.
HUNT4 and HUNT4 70+ were both performed in 2017-2019, and targeted all inhabitants and
inhabitants >70 years respectively in the former Nord-Trøndelag County. Jointly they include
broad health assessments using questionnaires, physical examinations, and tests.
Study aims Primary study aims are
1. to investigate if older age at the time of radical treatment has a negative impact on
self-reported QoL, function and local adverse effects in prostate cancer survivors
2. to investigate if health status, health problems, and use of health care services in
older prostate cancer survivors differ from a general male population of the same age
Secondary aims are
1. to investigate how local adverse effects after radical prostate cancer treatment may
influence QoL and functioning in both older and younger survivors, and to explore how
other factors such as treatment modality and comorbidity may influence these outcomes
2. to investigate if health status, health problems, and use of health care services in
younger prostate cancer survivors (being < 70 years by the time of treatment) differ
from a general male population of the same age
Study conduct
All men who are eligible according to the inclusion criteria (see sample size below and
inclusion criteria), will be invited to participate. All participants will provide written
informed consent.
In Study I, participants will be asked to fill in a questionnaire covering QoL (EORTC QLQ-C30
questionnaire), local adverse effects after prostate cancer treatment (the EPIC-26) and other
health problems (selected items from the HUNT4 Survey). Participants in Study I, who were 70
years or more by the time they received their cancer treatment, will subsequently be asked to
fill in an additional questionnaire covering a broader range of health issues also with items
from the HUNT4 Survey (Study IIA). Questionnaires will be administered by post with pre-paid
return envelopes attached.
To fulfill our aims, we will investigate the association between age at treatment and QoL,
self-reported health status, and local adverse effects (Primary aim 1). Furthermore, we will
compare self-reported health, health problems, and use of health care services between our
study population and the drawn control group (Primary aim 2 and Secondary aim 2). We will
also investigate how local adverse effects may influence prostate cancer survivors' QoL and
functioning (Secondary aim 1).
Sample size and statistics
About 1400 men with prostate cancer received curative treatment for local or localized
prostate cancer at Innlandet Hospital Trust from 2014 to 2018, and about 1200 of these are
estimated to be eligible for the initial study I. Matched controls will be drawn from the
HUNT4 and HUNT4 70+ surveys, distribution 1:3 (cancer survivors : controls).
Simple descriptive statistics will be used to describe our cohorts. Comparison between groups
will be made using parametric and non-parametric statistics as appropriate. To assess the
impact of age, treatment regimen and relevant confounding factors on outcomes, multiple
regression models will be estimated.
