Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)ADAPT-PNCT06019676
Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
An observational study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Royal Marsden NHS Foundation Trust at 12 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- How many people
- 170 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 26 Sep 2023to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males 18 years of age or older, with metastatic hormone sensitive prostate cancer
Who may be able to join
- 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
Who cannot join
- Non-metastatic prostate cancer
- Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
- Unable to complete patient reported outcome questionnaires
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Buckinghamshire Healthcare NHS Trust
Aylesbury, HP21 8AL
Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
Belfast, BT9 7AB
East Lancashire Hospitals NHS Trust
Blackburn, BB2 3HH
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, CF14 2TL
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, LA1 4RP
Clatterbrdige Cancer Centre, NHS Foundation Trust
Liverpool, CH63 4JY
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
South Tyneside and Sunderland NHS Foundation Trust
Newcastle, NE34 0PL
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN
The University Hospital of North Tees
Stockton-on-Tees, TS19 8PE
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
About this study
Official title: Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre 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 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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mHSPC and treatment decision for apalutamide by clinician | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide
Measured: August 2023 - April 2027
Secondary outcomes (3)
The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire
Measured: August 2023 - April 2027
The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire
Measured: August 2023 - April 2027
The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire
Measured: August 2023 - April 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start26 Sep 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
- Investigators
- Julia Murray, Dr., Principal investigator, The Royal Marsden Hospital, NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019676
- Sponsor's protocol ID
- CCR5793
- Acronym
- ADAPT-P
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06019676
- Acronym / sponsor ID
- ADAPT-P / CCR5793
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mHSPC and treatment decision for apalutamide by clinician | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males 18 years of age or older, with metastatic hormone sensitive prostate cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Non-metastatic prostate cancer
- Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
- Unable to complete patient reported outcome questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide
Time frame: August 2023 - April 2027
3 secondary outcomes
The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire
Time frame: August 2023 - April 2027
The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire
Time frame: August 2023 - April 2027
The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire
Time frame: August 2023 - April 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Murray, Dr. principal investigator
The Royal Marsden Hospital, NHS Foundation Trust
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Royal Marsden NHS Foundation Trust at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide (time frame: August 2023 - April 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.