Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Registration Number
- NCT06019676
- Lead Sponsor
- Royal Marsden NHS Foundation Trust
- Brief Summary
The ADAPT study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care. The clinical decision for patients to have apalutamide as part of their management plan will be decided by the clinician. The patient will only be approached about the ADAPT study if they decide they want to have apalutamide as part of their management.
The aims of the ADAPT study include documenting the biochemical effectiveness, as determined by the Prostate-Specific Antigen (PSA) and impact of apaluatmide on health related quality of life. The blood test for PSA is regularly monitored as standard of care.
Additionally, the impact of apalutamide on fatigue, cognitive function, patients reported outcomes, health related quality of life will be evaluated using patient questionnaires answered at defined timepoints. The questionnaires will be sent either electronically or via post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide.
Currently, the majority of data regarding tolerability and biochemical response to apalutamide has been from large phase III trials, where there are strict eligibility criteria. Real-world data as from the ADAPT study can provide valuable complementary data to randomised controlled trials, which can be used to address the 'generalizability' limitations of randomised control trials and can provide evidence on the external validity of their findings. This information can advance knowledge of patterns of care, treatment effectiveness and side-effects and inform clinical practice to improve outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 170
- Male 18 years of age or older
- Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:
- Metastatic hormone sensitive prostate cancer
- Treatment decision for apalutamide by clinician
- Non-metastatic prostate cancer
- Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
- Unable to complete patient reported outcome questionnaires
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 August 2023 - April 2027
- Secondary Outcome Measures
Name Time Method The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire August 2023 - April 2027 The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire August 2023 - April 2027 The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire August 2023 - April 2027
Trial Locations
- Locations (12)
The Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Buckinghamshire Healthcare NHS Trust
🇬🇧Aylesbury, United Kingdom
Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
🇬🇧Belfast, United Kingdom
East Lancashire Hospitals NHS Trust
🇬🇧Blackburn, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
🇬🇧Lancaster, United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
🇬🇧Cardiff, United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
🇬🇧Middlesbrough, United Kingdom
Clatterbrdige Cancer Centre, NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
The University Hospital of North Tees
🇬🇧Stockton-on-Tees, United Kingdom