Clinical trial NCT04995614: Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223
Official title: The Evaluation of the Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic Castration-resistant Prostate Cancer Patients Treated With Radium-223 Therapy, a Multicenter, Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castrate Resistant Prostate Cancer
Bone Metastases
Keywords: Radium-223
Health-related quality of life
Psychological distress
Fatigue
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2021-08-09
Enrollment: 122
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic castration-resistant prostate cancer patients who are treated with radium-223 in The Netherlands

Brief summary: The aim of the current prospective multicenter study is to evaluate cancer-specific and bone metastases related HR-QoL, psychological distress and fatigue in mCRPC patients before, during and after treatment with radium-223 in daily practice. Furthermore, the investigators aim to determine patient groups with identical health-related quality of life patterns over time, in order to identify variables related to health-related quality of life deterioration during the course of treatment, as patients with health-related quality of life deterioration may need specific attention to preserve health-related quality of life.

Detailed description: Radium-223 is a registered treatment option for patients with symptomatic bone metastatic castration-resistant prostate cancer. Previously, the phase 3 ALSYMPCA trial demonstrated that radium-223 improved overall survival and prolonged the time to the first symptomatic skeletal event and the time to first opioid use, irrespective of prior docetaxel chemotherapy. Subsequent analysis of the ALSYMPCA study showed that a significantly higher percentage of patients receiving radium-223 experienced meaningful HR-QoL improvement, as measured by the EQ-5D questionnaire and the FACT-P questionnaire, when compared to patients treated with placebo. However, studies evaluating health-related quality of life, psychological distress and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 in daily practice are lacking.

Eligibility criteria: Inclusion criteria:

* Metastatic castration-resistant prostate cancer;
* Undergoing treatment with radium-223 according to standard of care;
* Ability to comply with the study protocol, including completion of questionnaires on health-related quality of life;
* Written informed consent to the treating physician at the hospital site.

Exclusion criteria:

* Prior radium-223 therapy;
* Impaired cognitive functioning and/or illiteracy.

Primary outcomes:
measure: Cancer-specific health-related quality of life
timeFrame: 6 months
measure: Bone metastases related health-related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Intensity and location of bone pain
timeFrame: at baseline
measure: Psychological distress
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
Other outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Number of radium-223 injections
timeFrame: 6 months
measure: Trajectory analysis of health-related quality of life patterns over time
timeFrame: 6 months
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Arnhem
country: Netherlands
facility: Rijnstate ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair medisch centrum Groningen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud universitair medisch centrum (Radboudumc)
city: Roosendaal
country: Netherlands
facility: Bravis ziekenhuis
city: Sittard
country: Netherlands
facility: Zuyderland medisch centrum
Study officials:
affiliation: Radboud University Medical Center
name: Inge M. van Oort, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Doelen MJ, Oving IM, Wyndaele DNJ, van Basten JP, Terheggen F, van de Luijtgaarden ACM, Oyen WJG, van Schelven WD, van den Berkmortel F, Mehra N, Janssen MJR, Prins JB, Gerritsen WR, Custers JAE, van Oort IM. Health-related quality of life, psychological distress, and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 therapy. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):142-150. doi: 10.1038/s41391-022-00569-8. Epub 2022 Jul 8.