Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
NCT ID: NCT06019676
Last Updated: 2025-09-18
Study Results
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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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2023-09-26
2027-04-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with mHSPC and treatment decision for apalutamide by clinician
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:
* Metastatic hormone sensitive prostate cancer
* Treatment decision for apalutamide by clinician
Exclusion Criteria
* Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
* Unable to complete patient reported outcome questionnaires
18 Years
MALE
No
Sponsors
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Janssen, LP
INDUSTRY
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Julia Murray, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Royal Marsden Hospital, NHS Foundation Trust
Locations
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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
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, , United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, , United Kingdom
Clatterbrdige Cancer Centre, NHS Foundation Trust
Liverpool, , United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, , 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
Countries
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Other Identifiers
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CCR5793
Identifier Type: -
Identifier Source: org_study_id
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