Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223

NCT ID: NCT04995614

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-06-29

Brief Summary

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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

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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.

Conditions

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Castrate Resistant Prostate Cancer Bone Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Radium-223

Prospective observational cohort study investigating patient-reported outcomes

Intervention Type DRUG

Other Intervention Names

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Xofigo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inge M. van Oort, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status

Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status

Rijnstate ziekenhuis

Arnhem, , Netherlands

Site Status

Reinier de Graaf Gasthuis

Delft, , Netherlands

Site Status

Catharina ziekenhuis

Eindhoven, , Netherlands

Site Status

Universitair medisch centrum Groningen

Groningen, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Canisius-Wilhelmina ziekenhuis

Nijmegen, , Netherlands

Site Status

Radboud universitair medisch centrum (Radboudumc)

Nijmegen, , Netherlands

Site Status

Bravis ziekenhuis

Roosendaal, , Netherlands

Site Status

Zuyderland medisch centrum

Sittard, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 35804188 (View on PubMed)

Other Identifiers

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MOURO27

Identifier Type: OTHER

Identifier Source: secondary_id

AURIMPCA-2

Identifier Type: -

Identifier Source: org_study_id

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