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

Radboud University Medical Center

Status: Completed

Conditions: Bone Metastases; Castrate Resistant Prostate Cancer

Treatments: Drug: Radium-223

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04995614

MOURO27 (Other Identifier)

AURIMPCA-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.