Clinical trial NCT06019676: Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
Official title: Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2023-08-31
Enrollment: 170
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males 18 years of age or older, with metastatic hormone sensitive prostate cancer

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Non-metastatic prostate cancer
* Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
* Unable to complete patient reported outcome questionnaires

Primary outcomes:
measure: Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide
timeFrame: August 2023 - April 2027
Secondary outcomes:
measure: The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire
timeFrame: August 2023 - April 2027
measure: The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire
timeFrame: August 2023 - April 2027
measure: The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire
timeFrame: August 2023 - April 2027
Other outcomes:
measure: Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire
timeFrame: August 2023 - April 2027
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
state: Surrey
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
city: Belfast
country: United Kingdom
facility: Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
city: Blackburn
country: United Kingdom
facility: East Lancashire Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre, Velindre University NHS Trust
city: Lancaster
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Clatterbrdige Cancer Centre, NHS Foundation Trust
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Stockton-on-Tees
country: United Kingdom
facility: The University Hospital of North Tees
Study officials:
affiliation: The Royal Marsden Hospital, NHS Foundation Trust
name: Julia Murray, Dr.
role: PRINCIPAL_INVESTIGATOR
References: