Trial Title:
Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
NCT ID:
NCT06019676
Condition:
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Males 18 years of age or older, with metastatic hormone sensitive prostate cancer
Sampling method:
Non-Probability Sample
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Royal Marsden Hospital
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Greta Bucinskaite
Phone:
+442031865157
Email:
greta.bucinskaite@rmh.nhs.uk
Contact backup:
Last name:
Kelly Jones
Phone:
+442086613070
Email:
kelly.jones@rmh.nhs.uk
Investigator:
Last name:
Julia Murray, Dr.
Email:
Principal Investigator
Facility:
Name:
Buckinghamshire Healthcare NHS Trust
Address:
City:
Aylesbury
Zip:
HP21 8AL
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Alice Ngumo
Email:
alice.ngumo@nhs.net
Contact backup:
Last name:
Megan Oakley
Email:
megan.oakley2@nhs.net
Investigator:
Last name:
Prabir Chakraborti, Dr
Email:
Principal Investigator
Facility:
Name:
Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
Address:
City:
Belfast
Zip:
BT9 7AB
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Kathy Byrne
Email:
kathy.byrne@belfasttrust.hscni.net
Investigator:
Last name:
Laura Feeney, Dr.
Email:
Principal Investigator
Facility:
Name:
East Lancashire Hospitals NHS Trust
Address:
City:
Blackburn
Zip:
BB2 3HH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sarah Keith
Email:
sarah.keith@elht.nhs.uk
Investigator:
Last name:
Omi Parikh, Dr
Email:
Principal Investigator
Facility:
Name:
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Amy Strong
Phone:
+441223216083
Email:
amy.strong2@nhs.net
Investigator:
Last name:
Danish Mazhar, Dr.
Email:
Principal Investigator
Facility:
Name:
Velindre Cancer Centre, Velindre University NHS Trust
Address:
City:
Cardiff
Zip:
CF14 2TL
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Amanda Jackson
Email:
amanda.jackson2@wales.nhs.uk
Investigator:
Last name:
Elin S Evans, Dr.
Email:
Principal Investigator
Facility:
Name:
University Hospitals of Morecambe Bay NHS Foundation Trust
Address:
City:
Lancaster
Zip:
LA1 4RP
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Hilary Thatcher
Email:
hilary.thatcher@mbht.nhs.uk
Investigator:
Last name:
Alison Birtle, Prof
Email:
Principal Investigator
Facility:
Name:
Clatterbrdige Cancer Centre, NHS Foundation Trust
Address:
City:
Liverpool
Zip:
CH63 4JY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Kathryn Hughes
Phone:
+447955689143
Email:
ccf-tr.researchteam@nhs.net
Investigator:
Last name:
Isabel Syndikus, Prof.
Email:
Principal Investigator
Facility:
Name:
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Address:
City:
Middlesbrough
Zip:
TS4 3BW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Claire Elliott
Phone:
+4401642835568
Email:
claire.elliott4@nhs.net
Investigator:
Last name:
Darren Leaning, Dr.
Email:
Principal Investigator
Facility:
Name:
South Tyneside and Sunderland NHS Foundation Trust
Address:
City:
Newcastle
Zip:
NE34 0PL
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Judith McKenna
Email:
judith.mckenna1@nhs.net
Investigator:
Last name:
Rachel Pearson, Dr
Email:
Principal Investigator
Facility:
Name:
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Address:
City:
Newcastle
Zip:
NE7 7DN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Stuart Robertson
Email:
stuart.robertson@nhs.net
Investigator:
Last name:
Rachel Pearson, Dr.
Email:
Principal Investigator
Facility:
Name:
The University Hospital of North Tees
Address:
City:
Stockton-on-Tees
Zip:
TS19 8PE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lynda Poole
Email:
lynda.poole1@nhs.net
Investigator:
Last name:
Darren Leaning, Dr
Email:
Principal Investigator
Start date:
September 26, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Janssen, LP
Agency class:
Industry
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06019676
