Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
Recruiting
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Registration Number
- NCT06019676
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Male 18 years of age or older<br><br> - Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:<br><br> - Metastatic hormone sensitive prostate cancer<br><br> - Treatment decision for apalutamide by clinician<br><br>Exclusion Criteria:<br><br> - Non-metastatic prostate cancer<br><br> - Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for<br> prostate cancer<br><br> - Unable to complete patient reported outcome questionnaires
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide
- Secondary Outcome Measures
Name Time Method The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire;The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire;The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire