Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients

NCT06019676 | Active Not Recruiting

• 1 other identifier: CCR5793
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 12

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.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Outcome Measures

Primary Outcomes (1)

• Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide

  August 2023 - April 2027

Secondary Outcomes (3)

• The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire

  August 2023 - April 2027

• The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire

  August 2023 - April 2027

• The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire

  August 2023 - April 2027

Other Outcomes (1)

• Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire

  August 2023 - April 2027

Study Arms (1)

Patients with mHSPC and treatment decision for apalutamide by clinician

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males 18 years of age or older, with metastatic hormone sensitive prostate cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Janssen, LP: collaborator

Study Sites (12)

The Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Buckinghamshire Healthcare NHS Trust

Aylesbury, HP21 8AL, United Kingdom

Location

Northern Ireland Cancer Centre, Belfast Health & Social Care Trust

Belfast, BT9 7AB, United Kingdom

Location

East Lancashire Hospitals NHS Trust

Blackburn, BB2 3HH, United Kingdom

Location

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff, CF14 2TL, United Kingdom

Location

University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, LA1 4RP, United Kingdom

Location

Clatterbrdige Cancer Centre, NHS Foundation Trust

Liverpool, CH63 4JY, United Kingdom

Location

The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

South Tyneside and Sunderland NHS Foundation Trust

Newcastle, NE34 0PL, United Kingdom

Location

Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

The University Hospital of North Tees

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Study Officials

• Julia Murray, Dr.

  The Royal Marsden Hospital, NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 31, 2023
• Study Start: September 26, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)