ADAPT-P 

Status: Open

Specialty: Prostate

Date Opened: 13/08/2024

Planned Close Date: 31/12/2024

Sponsor: The Royal Marsden NHS Foundation Trust

Principal Investigator: Professor Alison Birtle

Study Title: Impact of apalutamide in metastatic hormone sensitive prostate cancer patients, a multi-centre prospective observational study 

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 PSA and impact of apaluatmide on health related quality of life. The blood test for PSA is regularly monitored as standard of care. The primary endpoint of the study will be to determine the number of patients with an undetectable PSA, defined as PSA < 0.2ng/ml by end of year 1 and year 2. 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.