NCT03948204

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

7.2 years

First QC Date

May 8, 2019

Last Update Submit

August 31, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Qality of life Global health status

    Global health status from QLQ-C30 version 3.0 scale

    3 years

  • Qality of life Physical functioning

    Physical functioning from QLQ-C30 version 3.0 scale

    3 years

  • Qality of life Role functioning

    Role functioning from QLQ-C30 version 3.0 scale

    3 years

  • Qality of life Emotional functioning

    Emotional functioning from QLQ-C30 version 3.0 scale

    3 years

  • Qality of life Cognitive functioning

    Cognitive functioning from QLQ-C30 version 3.0 scale

    3 years

  • Qality of life Social functioning

    Social functioning from QLQ-C30 version 3.0 scale

    3 years

Study Arms (2)

Prostate cancer

Men diagnosed with prostate cancer

Men without prostate cancer

Men without prostate cancer matched for age and county

Eligibility Criteria

Age0 Years - 110 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All men with prostate cancer in Norway

You may qualify if:

  • All patients diagnosed with prostate cancer in Norway at or after 01.01.2017

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cancer Registy of Norway

Oslo, 0377, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Head, Registry Dept

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 13, 2019

Study Start

January 1, 2017

Primary Completion

March 31, 2024

Study Completion

December 31, 2024

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations