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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mHSPC and treatment decision for apalutamide by clinician |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire | August 2023 - April 2027 | |
| The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire | August 2023 - April 2027 |
| Measure | Description | Time Frame |
|---|---|---|
| Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire | August 2023 - April 2027 |
Inclusion Criteria:
Exclusion Criteria:
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Males 18 years of age or older, with metastatic hormone sensitive prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Julia Murray, Dr. | The Royal Marsden Hospital, NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom | ||
| Buckinghamshire Healthcare NHS Trust |
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| The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire | August 2023 - April 2027 |
| Aylesbury |
| HP21 8AL |
| United Kingdom |
| Northern Ireland Cancer Centre, Belfast Health & Social Care Trust | Belfast | BT9 7AB | United Kingdom |
| East Lancashire Hospitals NHS Trust | Blackburn | BB2 3HH | United Kingdom |
| Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Velindre Cancer Centre, Velindre University NHS Trust | Cardiff | CF14 2TL | United Kingdom |
| University Hospitals of Morecambe Bay NHS Foundation Trust | Lancaster | LA1 4RP | United Kingdom |
| Clatterbrdige Cancer Centre, NHS Foundation Trust | Liverpool | CH63 4JY | United Kingdom |
| The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust | Middlesbrough | TS4 3BW | United Kingdom |
| South Tyneside and Sunderland NHS Foundation Trust | Newcastle | NE34 0PL | United Kingdom |
| Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle | NE7 7DN | United Kingdom |
| The University Hospital of North Tees | Stockton-on-Tees | TS19 8PE | United Kingdom |