Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03948204 |
| Other study ID # |
0910 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Cancer Registry of Norway |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
"Life after prostate cancer" is a prospective, population-based, case-control study where all
men diagnosed with Prostate cancer (PCa) from 01.01.2017 regardless of age and disease stage
are invited to a survey by questionnaire on their health. Men with no history of PCa are
identified through the National Registry, matched on age and region of residence, and invited
to the survey as controls. Patients and controls who have signed up for an official digital
mailbox are invited electronically. Those who do not have a digital mailbox are invited by
regular mail. All participants have given their informed consent for all linkages planned in
this study. Due to electronic reporting of histological reports to the Norwegian Prostate
Cancer Registry, patients are invited to the survey shortly after diagnosis. More than 6 400
patients have submitted questionnaires per April 2019.
Description:
Survey participants complete questionnaires on adverse effects / functional outcomes and QoL.
The survey questionnaire includes EQ-5D-5L and EORTC QLQ-C3). EPIC-26 is used together with
additional questions on sexual interest and use of aids. Highest level of education, height,
weight and marital status are also included at baseline. All those with PCa, as well as the
men without PCa who participate at baseline, are invited to submit follow-up questionnaires 1
and 3 years after diagnosis. The same instruments are then used with the addition of
questions on work ability together with questions on treatment and experience with the health
care service including shared decision making. From Statistics Norway data on personal and
household income will be available together with education level stated by participants. The
Norwegian Prostate Cancer Registry, a national quality registry on PCa, is incorporated in
The Cancer Registry of Norway and is in collaboration with clinical specialists from
hospitals in all regions of the country. The registry publishes results regularly to patients
and hospitals with updated statistics on incidence, work-up, treatment choice and outcomes.
All variables concerning work-up, diagnosis (histopathological data, imaging) stage (cTNM,
PSA, Gleason score), treatment (surgery, radiotherapy, endocrine treatment) and follow-up are
available for linkage with questionnaire data from the patients. Patients will be stratified
into low-, intermediate-, and high-risk groups as defined by the European Association of
Urology based on the clinical T-category (cT), the PSA level, and the Gleason score (GS) at
the time of diagnosis. Low-risk: cT1-T2a and PSA<10 ng/mL and GS<7, Intermediate-risk: cT2b
or PSA 10-20 ng/ml or GS=7, high-risk localised: cT2c or PSA>20 ng/mL or GS>7, high-risk
locally advanced: cT3-4 or cN1. Division will further be by initial treatment: radical
prostatectomy, radiotherapy ≥74 Gy by standard fractionation with or without hormone
treatment, or no local treatment consisting of active surveillance or watchful waiting. The
Norwegian Patient Registry contains data on all individuals waiting for treatment or that
have received treatment including both in- and outpatient specialist care. A modified version
of the Charlson's comorbidity index shown to be valid for patient registry data will for this
study be used.
