OPEN Research Support
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MD. Ph.d.. Klinisk lektor
Lars Fokdal MD. Ph.d.. Klinisk lektor
Onkologisk Afdeling Vejle Sygehus, Syddansk Universitetshospital


Project management
Project status    Open
 
Data collection dates
Start 28.05.2025  
End 01.05.2030  
 



BPL-01. Bivirkningsregistrering, patientrapporterede følger og livskvalitet for patienter som modtager strålebehandling for prostatakræft med helbredende sigte

Short summary

Prostate cancer is the most common type of cancer in the pelvis. Treatment include either surgery or radiotherapy eventually in combination with ADT. Radiotherapy is associated with acute and late side effects affecting the bowel, bladder, and other organs and structures in the pelvis. To alleviate patients' side effects during treatment and in the years after completing radiation therapy, as well as to optimize future treatment this longitutional registration study has been initiated


Rationale

The primary purpose of this study is to explore and systematically collect acute and late side effects and patient-reported quality of life (PROMs) after curative radiation therapy for prostate cancer. These data will be used to optimize and further develop improved future radiation treatments. Additionally, the aim of the study is to investigate survival following radiation therapy.


Description of the cohort

A total of 450 patients with prostatecancer has been included in the study. Presently inclusion has been finalised but we are still collection follow-up data with planned follow-up of 5 years.


Data and biological material

Registrations of both side effects and patient-reported quality of life (PROMs) are conducted before the start of radiotherapy, at the end of treatment, and then continuously over a period of up to five years. The frequency of registration decreases over time, beginning with four times annually in the first year and decreasing to once annually in the fifth and final year. Clinical side effects and events are recorded and graded according to CTCAE (v4.0). PROMs are gathered using a quality of life questionnaire based on the Expanded Prostate Cancer Index Composite (EPIC, University of Michigan) as well as the EORTC QLQ-PR25.


Collaborating researchers and departments

Department of Oncology, Vejle Hospital

  • Christine Madsen
  • Martin Berg
  • Henrik Dahl Nissen
  • Christina Bøgh Jakobsen